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Overview of:

HEALTHCARE
COMPLIANCE

Sarah Godwin Brinson Lesley Clack


Larecia Money Gill Laura Kim Gosa

Blue Ridge | Cumming | Dahlonega | Gainesville | Oconee


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TABLE OF C ONTENT S
Introduction to Healthcare Compliance 1
1.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.4 The History of Healthcare in the United States . . . . . . . . . . . . . . 2

1.5 Healthcare Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.6 Benefits of Compliance Programs . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.7 Compliance Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.8 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.9 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.10 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

1.11 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Ethics and Law 17


2.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.4 Ethical Challenges in Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.5 Legal Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.6 Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

2.7 Fraud and Abuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.8 Implications for Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.9 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.10 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

2.11 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

2.12 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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Health Insurance & Reimbursement 30
3.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.4 Historical Evolution of Payer Models . . . . . . . . . . . . . . . . . . . . . 31

3.5 Types of Insurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3.6 Innovative New Approaches to the Payer/Provider Model . . . 38

3.7 Health Insurance Related Laws and Regulations . . . . . . . . . . . 40

3.8 Oversight and Regulation of Reimbursement Practices . . . . . 43

3.9 Regulatory Statutes and Programs . . . . . . . . . . . . . . . . . . . . . . . 45

3.10 Implications for Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

3.11 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

3.12 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

3.13 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

3.14 References: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Quality Improvement 55
4.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

4.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

4.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

4.4 Patient-Centered Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

4.5 Care Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

4.6 Evidence-Based Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

4.7 Quality Control & Workflow Design . . . . . . . . . . . . . . . . . . . . . . 61

4.8 Data Analysis and Analytics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.9 Quality Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.10 Implications for Compliance & Summary . . . . . . . . . . . . . . . . 63

4.11 Discussion Questions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

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4.12 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

4.13 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Strategic Planning 68
5.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5.4 Leadership and Strategic Planning . . . . . . . . . . . . . . . . . . . . . . . 69

5.5 Foundation of a Strategic Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

5.6 Mission, Vision, Values, and Goals . . . . . . . . . . . . . . . . . . . . . . . 71

5.7 Communicating the Strategic Plan . . . . . . . . . . . . . . . . . . . . . . . 74

5.8 Strategic Planning in Health Care . . . . . . . . . . . . . . . . . . . . . . . . 75

5.9 Implications for Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

5.10 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5.11 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

5.12 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

5.13 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Managing Healthcare Professionals & Strategic


Management of Human Resources 80
6.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

6.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

6.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

6.4 Understanding the Management of Healthcare Professionals in


the Workforce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

6.5 Management and Human Resources . . . . . . . . . . . . . . . . . . . . . 82

6.6 Managing conflict in the workplace . . . . . . . . . . . . . . . . . . . . . . . 82

6.7 Employee Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

6.8 Components of Human Resource Management . . . . . . . . . . . . 86

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6.9 Aligning Human Resource Strategies with the Health Care
Workforce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

6.10 Implications for Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

6.11 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

6.12 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

6.13 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

6.14 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Healthcare Technology 92
7.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.4 Meaningful Use (MU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

7.5 Patient Support Tools/Decision Support Tools . . . . . . . . . . . . . 95

7.6 Clinical Decision Support Systems . . . . . . . . . . . . . . . . . . . . . . . 98

7.7 Telehealth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

7.8 Standardized Medical Language . . . . . . . . . . . . . . . . . . . . . . . . 100

7.9 Implementing an Electronic Health Record . . . . . . . . . . . . . . . 101

7.10 Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

7.11 Interfaces, Health Information Exchanges, and Health


Information Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

7.12 Sharing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

7.13 Implications for Compliance and Summary . . . . . . . . . . . . . . 109

7.14 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

7.15 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

7.16 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Special Topics and Emerging Issues in Healthcare


Management 115
8.1 Learning Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

8.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

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8.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

8.4 Emerging Issues in Health Care . . . . . . . . . . . . . . . . . . . . . . . . . 116

8.5 Person-Centered Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

8.6 Future of Personalized Health Care . . . . . . . . . . . . . . . . . . . . . 118

8.7 Challenges with Health Reform . . . . . . . . . . . . . . . . . . . . . . . . . 119

8.8 Workforce Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

8.9 Implications for Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

8.10 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

8.11 Discussion Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

8.12 Key Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

8.13 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

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1
1.1 LEARNING OBJECTIVES
Introduction to
Healthcare Compliance

1. Describe how the U.S. has become a major player in global health and
what role healthcare compliance plays in the healthcare industry.
2. Explain how a healthcare compliance program works.
3. Discuss why compliance programs are important to healthcare
organizations.
4. Discuss the benefits of initiating a healthcare compliance program.

1.2 INTRODUCTION
The United States has been at the forefront of globalized health care for many
years by influencing international healthcare policy and establishing international
healthcare agencies to address global health threats such as HIV/AIDS, tuberculosis,
and malaria. It has also been a leader in medical innovation and technology over
the past two decades, a time of many changes in the world of healthcare. Due to
these changes, the rules, regulations, and legislation are also constantly changing,
making healthcare compliance a challenge. This chapter will discuss the rise of
U.S. healthcare on the global stage, define healthcare compliance, and discuss
penalties for noncompliance.

1.3 KEY TERMS


• Centers for Medicare and Medicaid Services (CMS)
• Chief Executive Officer (CEO)
• Compliance Officer
• Healthcare compliance
• Office of Inspector General (OIG)
• Third-Party Payer

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

1.4 THE HISTORY OF HEALTHCARE IN THE


UNITED STATES
With the compliance minded industry and standards of today’s healthcare in
mind, it is difficult to imagine a time when the United States was not the highly
regulated powerhouse of medical technology and innovation that it is now.
However, prior to the 18th century, health care in the U.S. was practiced informally
with little training required. By the late 1700s, medical schools began appearing in
the U.S. which provided formalized training for physicians.
In the late 1700s, the industrial revolution also began in the U.S. and lasted over
a century. With the industrial revolution came an increase of jobs in steel mills and
with the railroad. Coincidentally, job-related injuries increased due to the nature
of this work. Increase in injuries further occurred due to the U.S.’s involvement
in numerous wars. These events compelled healthcare practitioners to develop
innovative medical treatments—and thus launched the U.S.’s global dominance in
healthcare technology and innovation.
During the 19th and 20th centuries, American scientists and physicians developed
medical breakthroughs ranging from immunizations and antibiotics to surgical
and cardiovascular treatments. These treatments soon spread internationally
and became the standard of care worldwide. As medical advances continued, the
U.S. realized their impact on a global scale and the importance of ensuring these
treatments were available to all global citizens. This realization inspired the U.S.
to invest in global health initiatives such as HIV/AIDS relief and immunization
programs. Many view foreign aid simply as support for the international community;
however, the U.S. recognizes this aid assists more than the recipient country.
Foreign aid prevents pandemic outbreaks of infectious diseases and promotes
increased productivity and economic growth internationally (National Academy of
Sciences, 2017). By improving the health and financial stability of global citizens,
the U.S. protects American citizens located both abroad and at home.
The U.S. attracts the world’s smartest and most talented scientist and
researchers by offering financial incentives provided by our capitalist system.
Capitalism allows for efficient allocation of resources and production and a creative
and economic freedom not available in all countries; it also drives business and
profits within the U.S. (Pettinger, 2019). Because of these advantages, the U.S.
leads the world in medical technology and treatments, as shown through their
state-of-the-art medical facilities, advanced treatment protocols, and access to
technology and innovation in U.S. facilities (Thorpe, 2011).

1.5 HEALTHCARE COMPLIANCE


Over the last two decades, the healthcare industry has experienced stable
growth for several reasons, including population growth, population aging, disease
prevalence, medical advancements, and utilization of services (Probasco, 2019).
Due to advances in medical treatment, the average lifespan of most people has

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

been extended. Consequently, healthcare providers are caring for patients who are
older with more comorbidities than in years past. Healthcare providers are also
seeing these patients in diverse care settings, including health clinics, physician’s
offices, hospitals, and domestic spaces. In order to receive reimbursement, health
care providers must adhere to the laws, policies, and procedures that are in place to
regulate these care settings. However, many agencies regulate these care practices,
including federal and state legislatures and administrative agencies, such as the
Internal Revenue Service (IRS), the Department of Health and Human Services
(HHS), and the Centers for Medicare and Medicaid Services (CMS) (Safian, 2009).
These agencies guide and inform healthcare providers of their responsibilities in
providing patient care, including reimbursement practices.
Due to the sheer number of laws, policies, and regulatory agencies in place
to keep up with the healthcare industry’s growth, it is difficult to understand,
much less remain compliant with, the standards of practice. In order to ensure
compliance with these regulations, healthcare facilities have developed compliance
programs. These programs interpret laws and regulations and translate them
into language that healthcare providers can understand. After this process has
occurred, members of the compliance team (usually referred to as compliance
officers) then educate staff—including health care professionals—on how these
laws and regulations impact their health care practice. A compliance program
also develops policies regarding how violations are reported and determines what
sanctions will be enforced for noncompliance. Therefore, compliance programs
have three distinct roles: prevention, detection, and correction (Hartunian, Wolff,
& Seigel, 2018). According to the Office of Inspector General (2011), seven key
elements of a compliance program fit under each of the roles:

1.5.1 Role 1, Prevention:

1. Written policies/procedures: all policies and procedures should be


located in a document that is readily accessible to all employees of the
organization. Along with the policies and procedures, there should be
information included in this document that details the implementation
and operation of the compliance program.
2. Compliance professionals: the organization should designate a
compliance officer to oversee the organization’s compliance efforts. This
individual needs to have enough autonomy and authority to conduct
the position’s duties without interference. This position should report
directly to the Chief Executive Officer (CEO) and/or the Board of
Directors. A compliance committee should also be in place and meet at
least twice per year to review any grievances filed and quality reports
(which are required as part of the internal auditing process).
3. Effective training: once policies and procedures are in place, the
compliance officer should implement a training program with all

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

employees that covers general compliance issues; fraud, waste, and


abuse; the Anti-Kickback Statute (AKS); the False Claims Act; and
the issue of inappropriate gifts/relationships with referral sources
(Hartunian, Wolff, & Seigel, 2018). The training should be documented
and offered upon hiring and annually thereafter.
4. Effective communication: in addition to training, employees should
be informed of confidential, anonymous ways they can report compliance
concerns. This may be achieved by offering a hotline or an email address
that should be shared with all employees using multiple methods (i.e.,
email, printed flyer, etc.).

1.5.2 Role 2, Detection:

5. Internal monitoring: in addition to regularly monitoring the


compliance hotline, the compliance officer should also perform an annual
risk assessment. This assessment includes regular meetings with staff
to identify risks, compliance challenges, and areas of noncompliance. A
written report should be developed and presented to senior leadership,
along with strategies to address these issues and avoid future violations.

1.5.3 Role 3, Corrective Action:

6. Enforcement of standards: disciplinary approaches that are


consistently applied to all employees should be outlined in the
compliance program. Anyone found to violate the compliance standards
by participating in unlawful or unethical actions should be terminated.
7. Prompt response: investigations of reported noncompliance must be
conducted quickly to avoid a False Claim Act (FCA) case. Organizations
have sixty days from the time a violation is reported to respond in cases
of overpayment.

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

Real-Life Example

In 2018, the U.S. Department of Justice (US DOJ) prosecuted the largest
healthcare fraud case in history. The nationwide case involved 58 districts
and 601 defendants (including 165 doctors, nurses, and other professionals)
who filed approximately $2 billion in false claims and 30 state Medicaid Fraud
Control Units (MFCUs). Of those charged, 76 physicians were indicted for
prescribing and distributing opioids and other narcotics, and 2,700 individuals
were excluded from participating in Medicare, Medicaid, and all other federal
healthcare programs (US DOJ, 2018). The government has indicated its level
of support for preventing Medicare and Medicaid fraud, waste, and abuse by
including $751 million in funding for monitoring and investigating such cases
for fiscal year 2018 (Hartunian, Wolff, & Seigel, 2017).
Source: Manatt
Attribution: (Hartunian, Wolff, & Seigel, 2017)
License: Fair Use

1.6 BENEFITS OF COMPLIANCE PROGRAMS


Health care is dynamic and constantly changing, with medical advancements
occurring daily. Along with these advancements come updated rules, regulations,
and laws. It is impossible for healthcare facilities to remain knowledgeable of these
changes and compliant with the multitudes of regulatory agencies that oversee
the implementation and compliance of these changes. Therefore, instituting a
compliance program that will monitor for these changes and implement any
needed program revisions to ensure compliance is a major benefit. In addition
to monitoring for changes, compliance officers interpret the rules, regulations,
and laws, and provide written guidelines that are easily understood. They then
educate all staff members on the guidelines, monitor for adherence, and provide
corrective measures before regulatory agencies are alerted and/or issue sanctions.
Compliance programs also offer staff an internal means for reporting violations.
Outcomes of effective compliance programs include increased staff knowledge
and adherence to regulations, improved safety and service to patients, and reduced
liability resulting in increased revenue (Safian, 2009). Staff cannot adhere to rules
and regulations of which they are unaware. However, ignorance of the regulation
is not a defense, as most laws are written using the phrase “knows or should
know.” Therefore, it is essential that healthcare organizations ensure that staff
are properly educated on their responsibilities; often, this task is a requirement
of the laws themselves. However, this information must be explained in an
easily understood manner so as to avoid any possible confusion that may lead to
inadvertent violations.
Health care compliance thus leads to improved patient safety and service
due to strict adherence to established policies and procedures. These policies
and procedures cover services ranging from medical coding to patient care

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

documentation. Each of these services contributes to positive patient outcomes


by ensuring the patient’s diagnosis is documented accurately and the patient
receives the appropriate medical care related to the diagnosis. By complying with
the policies and procedures, the risk of committing a medical error is reduced and
the likelihood of negative patient outcomes decreased.
Each year, approximately 400,000 patients who are hospitalized experience
harm from preventable medical errors (James, 2013). These errors result in the
deaths of over 100,000 people annually and cost approximately $20 billion per
year in such direct costs as litigation and patient treatments due to medical errors
and such indirect costs as decreased productivity and staff absenteeism related to
event investigations and court appearances (Blair, 2012; Ditmer, 2010; Neilsen
& Einarsen, 2012). An additional consequence of noncompliance is lost revenue
due to facility and/or physician exclusion from participation with Medicare,
Medicaid, or other third-party payers. Decreasing medical errors lessens the
chances of developing negative patient outcomes, which results in fewer lawsuits
and a reduced loss of revenue. One solution to address this potential problem is
to implement and uphold a culture of safety that adheres to prescribed standards
of care (Rodziewicz & Hipskind, 2019). Healthcare compliance programs are
one way to ensure your organization is practicing within the confines of the law
and maintaining this culture of safety. Compliance programs also convey the
organization’s intent to adhere to policies, procedures, and laws. The very existence
of a compliance program within an organization may result in lower penalties and
fines if an organization is found guilty of violating federal laws.

1.7 COMPLIANCE DOCUMENTATION


In health care, the basic rule of “if it is not documented then you did not do
it” is the golden rule regarding compliance. It doesn’t matter if your facility is
100% compliant with regulations; if it isn’t documented then you are considered
noncompliant. The benefits of documentation are evident: documentation lends
support for compliance! However, other benefits may not be as evident; for instance,
documentation provides information to assist with decision making for patient care
and provides a means for communication between providers to ensure continuity
of patient care and increased patient safety (Safian, 2009). Documentation can also
lead to public safety measures by identifying trends in illnesses and outcomes of
health promotion programs. This data can also be used when conducting research
to assist in determining the most effective treatment modalities and to develop
updated care protocols. Based on data (documentation) collected, organizations
can determine how to distribute equipment, staff, finances (i.e., budget), and
other resources to ensure they are allocated appropriately and equitably based
on the department’s needs (Sabian, 2009). Documentation can also be reviewed
to identify areas of potential risks and guide quality improvement measures. One
additional benefit of documentation is accurately reflecting patients’ diagnoses

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

and treatments rendered for billing purposes. If patient visits are not documented
accurately, then they will not be coded properly, which will affect reimbursement
for the visit. More importantly, if the payer reimbursed the physician and/or
organization for incorrect treatments and/or diagnoses, the offending agent can
be charged with making false claims and fined (including repaying any monies
received), charged with criminal acts, risk incarceration, and/or lose the ability to
participate in treating Medicare/Medicaid patients.

False Claim Act

Liability

The statute begins, in § 3729(a), by explaining the conduct that creates FCA
liability. In very general terms, §§ 3729(a)(1)(A) and (B) set forth FCA liability
for any person who knowingly submits a false claim to the government or causes
another to submit a false claim to the government or knowingly makes a false
record or statement to get a false claim paid by the government. Section 3729(a)
(1)(G) is known as the reverse false claims section; it provides liability where one
acts improperly—not to get money from the government but to avoid having to
pay money to the government. Section 3729(a)(1)(C) creates liability for those
who conspire to violate the FCA. Sections 3729(a)(1)(D), (E), and (F) are rarely
invoked. Damages and penalties: After listing the seven types of conduct that
result in FCA liability, the statute provides that one who is liable must pay a civil
penalty of between $5,000 and $10,000 for each false claim (those amounts are
adjusted from time to time; the current amounts are $5,500 to $11,000) and
treble the amount of the government’s damages. If a person who has violated the
FCA reports the incident to the government under certain conditions, the FCA
provides that the person shall be liable for not less than double the damages.
The knowledge requirement: A person does not violate the False Claims Act
by submitting a false claim to the government unwittingly; to violate the FCA
a person must have submitted, or caused the submission of, the false claim (or
made a false statement or record) with knowledge of the falsity. In § 3729(b)
(1), knowledge of false information is defined as being (1) actual knowledge, (2)
deliberate ignorance of the truth or intentionally falsifying information, or (3)
reckless disregard of the truth or falsifying information.
(Department of Justice, 2011)
Source: The United States Department of Justice
Attribution: The United States Department of Justice
License: Public Domain

All individuals who document in a patient’s record are responsible for


providing complete, accurate records that are easily accessible to others involved
in the patient’s care (Safian, 2009). The importance of this procedure cannot be
understated: the inclusion and/or exclusion of vital information may impact third-

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

party payers’ decisions to reimburse providers and/or organizations for services.


For example, the Centers for Medicare and Medicaid Services (CMS) published a
list of “never events” for which they will not pay for care associated with such events.
Incidents such as operating on the wrong body part, leaving a foreign body in a
patient after surgery, severe pressure ulcers, and mismatched blood transfusions
are examples of “never events.” These events are costly to the healthcare facility,
which must cover all costs associated with each occurrence. For example, catheter
associated urinary tract infections (CAUTIs) are considered to be hospital acquired
infections and cost up to $29,743 per occurrence to treat (Agency for Healthcare
Research and Quality, 2017).

Case Example

Mrs. Jones, a 72-year-old female, is admitted to the hospital with a diabetic


ketoacidosis diagnosis. Upon admission to the ICU, the admitting nurse fails to
document a pressure ulcer that was located in Mrs. Jones’ lower back. The next
day, the nurse assigned to care for Mrs. Jones discovers the pressure ulcer and
documents it in her assessment. Because the pressure ulcer was not properly
identified and documented upon admission, CMS considers this condition as a
hospital acquired state and, therefore, refuses to pay the charges associated with
care rendered for this problem.
Source: Original Work
Attribution: Larecia Gill
License: CC BY-SA 4.0

Documentation must also be completed in a timely manner. With the


national mandate for the use of electronic health records (EHR) by all physicians
and organizations who treat patients covered by governmental insurance,
documentation is recorded in real time, thus entries are time stamped (Atherton,
2011). Therefore, providers can no longer document when it is convenient for them
but must record their assessments and treatment plans in the immediate period
following the patient encounter. Along with these essential elements, providers
must also confirm the entry was created by them by providing their signature
(either electronically or manually) (Safrian, 2009).
Another essential component of documentation is legibility. This issue has
been greatly improved with the implementation of EHR. However, it is still
important for providers to be knowledgeable on approved abbreviations for use
in documentation. The Joint Commission (2019) developed a list of unapproved
abbreviations that should never be used when documenting. They also provide a list
of abbreviations, acronyms, and symbols that should be used with extreme caution
due to the high risk of confusion and/or misinterpretation. Each organization
determines which abbreviations to include on their “Do Not Use” list. Therefore,
healthcare professionals are responsible for knowing these institutional policies.

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

Do Not Use Potential Problem Use Instead


U (unit) Mistaken for “0” (zero), the Write “unit”
number “4” (four) or “cc”
IU (International Unit) Mistaken for IV (intravenous) Write “International
Unit”
or the number 10 (ten)
Q.D., QD, q.d., qd(daily) Mistaken for each other Write “daily”
Q.O.D., QOD, q.o.d, qod Period after the Q mistaken Write “every other day
for
(every other day)
“I” and the “O” mistaken for
“I”
Trailing zero (X.0 mg)* Decimal point is missed Write X mg
Lack of leading zero (.X Write 0.X mg
mg)
MS Can mean morphine sulfate or Write “morphine sulfate”
magnesium sulfate Write “magnesium sulfate”
MSO4 and MgSO4 Confused for one another Write “morphine sulfate”
Write “magnesium sulfate”
*Exception: A “trailing
zero” may be used
only where required to
demonstrate the level
of precision of the value
being reported, such as for
laboratory results, imaging
studies that report size of
lesions, or catheter/tube
sizes. It may not be used
in medication orders or
other medication-related
documentation.
Table 1.1: The Joint Commission Official “Do Not Use” List (2019)
Source: The Joint Commission
Attribution: The Joint Commission
License: © The Joint Commission, 2021. Reprinted with permission.

Do Not Use Potential Problem Use Instead


> (greater than) Misinterpreted as the number Write “greater than”
“7” (seven) or the letter “L”
< (less than) Write “less than”
Confused for one another
Abbreviations for drug Misinterpreted due to similar Write drug names in full
names abbreviations for
multiple drugs

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

Apothecary units Unfamiliar to many Use metric units


practitioners
Confused with metric units
@ Mistaken for the number “2” Write “at”
(two)
cc Mistaken for U (units) when Write “mL”
poorly written or “ml” or “milliliters” (“mL”
is preferred)
μg Mistaken for mg (milligrams) Write “mcg” or “micrograms”
resulting in one thousand-fold
overdose
Table 1.2: Additional Abbreviations, Acronyms and Symbols (For possible future inclusion in the
Official “Do Not Use” List)

Source: The Joint Commission

Attribution: The Joint Commission

License: © The Joint Commission, 2021. Reprinted with permission.

Regardless of the setting where a patient encounter occurs, certain details must be
included to meet compliance regulations, such as the following:

• Date of patient encounter


• Identification of patient: including patient’s full name, address, phone
number, date of birth, and emergency contact information
• Internal patient identifier (i.e., medical record number, patient
number)
• Identification of treating provider
• Reason(s) for encounter (i.e., diagnosis, chief complaint)
• Details of encounter:
◊ Subjective Data (based on personal opinion, interpretation, point of
view):
▪ Discussions
▪ Communications
▪ History of present illness (HPI)
▪ Past medical history (PMH)
▪ Family and social history
▪ Allergies
▪ Medications
▪ Previous surgeries

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

◊ Objective Data (fact-based, measurable and observable):


▪ Findings of physical examination
▪ Labs or procedures (with results)
▪ Healthcare provider’s interpretation/diagnoses, including any
prescriptions provided and recommendations for follow-up
• Healthcare provider’s signature
(Department of Justice, 2011)

Figure 1.1: Essential Components of Documentation


Source: Original Work
Attribution: Larecia Gill
License: CC BY-SA 4.0

Laws and accrediting bodies may require elements in addition to the ones stated
above to meet compliance regulations. For example, the False Claim Act requires
that documentation demonstrates medical necessity for a prescribed treatment,
service, or medical equipment (Department of Justice, 2011). Certificates of Medical
Necessity (CMN) must be completed by the prescribing healthcare provider before
third-party payers will pay for the service/equipment. An example of a CMN
appears on the following pages.

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

Figure 1.2a: Certificate of Medical Necessity Page 1


Source: Centers for Medicare and Medicaid Services
Attribution: Centers for Medicare and Medicaid Services
License: Public Domain

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

Figure 1.2b: Certificate of Medical Necessity Page 2


Source: Centers for Medicare and Medicaid Services
Attribution: Centers for Medicare and Medicaid Services
License: Public Domain

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

As you can see, many elements constitute compliance in healthcare settings.


Lack of knowledge is not an acceptable excuse for noncompliance. It is every
employee’s responsibility to ensure they are compliant and/or report areas of
noncompliance to be addressed immediately. Compliance programs provide
guidance on regulatory issues and regulate the organization’s activities to ensure
compliance. The roles of compliance programs are threefold: prevention, detection,
and correction. Healthcare employees need to be aware of their organization’s
policies and procedures to avoid disciplinary action, up to and including termination
and/or incarceration.

1.8 SUMMARY
Health care in the U.S. has evolved over the past few centuries. As the U.S.
continues to exert its global dominance in healthcare, organizations are tasked with
complying with laws, regulations, policies, and procedures dictated by accrediting
agencies. Compliance programs are one way healthcare organizations can ensure
they are following these statutes and avoid being penalized.

1.9 DISCUSSION QUESTIONS


1. What is a compliance program?
2. Discuss the role of a compliance officer.
3. Discuss the benefits of a compliance program.
4. Who is responsible for ensuring a health care organization’s compliance?
5. Based on the Joint Commission’s list of unapproved abbreviations,
indicate the appropriate category for each abbreviation: Unapproved or
Discouraged

Abbreviation List UNAPPROVED DISCOURAGED


cc
IU
MSO4
Trailing zero (X.0 mg)
> (greater than)
@
QD (qd)
µg
U (u)

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

1.10 KEY TERM DEFINITIONS


1. Centers for Medicare and Medicaid Services (CMS) – the federal agency
that runs the Medicare, Medicaid, and Children’s Health Insurance
Programs. CMS is a division of the Department of Health and Human
Services (HHS).
2. Chief Executive Officer (CEO) – the highest-ranking person in a company
or other institution who is ultimately responsible for making managerial
decisions.
3. Compliance Officer – an individual who ensures that a company complies
with its outside regulatory and legal requirements as well as internal
policies and bylaws.
4. Healthcare compliance – the process of following rules, regulations, and
laws that relate to healthcare practices.
5. Office of Inspector General (OIG) – the federal agency responsible for
ensuring that the health care industry complies with fraud and abuse
laws. OIG also seeks to educate the public about fraudulent schemes so
that individuals can protect themselves and report suspicious activities.
6. Third-Party Payer – an entity (other than the patient or the health care
provider) that reimburses and manages healthcare expenses.

1.11 REFERENCES
Agency for Healthcare Research and Quality. (2017). Estimating the additional hospital
inpatient cost and mortality associated with selected hospital-acquired conditions.
Retrieved from https://www.ahrq.gov/hai/pfp/haccost2017-results.html
Atherton, J. (2011). Development of the electronic health record. AMA Journal of Ethics,
Virtual Mentor, 13(3):186-189. doi: 10.1001/virtualmentor.2011.13.3.mhst1-1103.
Blair, P.L. (2012). Lateral violence in nursing. Journal of Emergency Nursing, 38, 1-4.
doi: 10.1016/j.jen.2011.12.006
Department of Justice. (2011). The False Claims Act: A Primer. Retrieved from https://
www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-FRAUDS_FCA_
Primer.pdf
Ditmer, D. (2010). A safe environment for nurses and patients: Halting horizontal
violence. Journal of Nursing Regulation, 1(3), 9-14.
Hartunian, R.S., Wolff, J.C., & Seigel, R. (2017, November). Fraud and abuse 2017:
Understanding trends and avoiding actions. Retrieved from https://www.manatt.
com/Insights/Newsletters/Health-Update/Fraud-and-Abuse-2017-Understanding-
Trends-and-Avoi?utm_source=healthupdatenewsletter&utm_medium=email&utm_
campaign=healthupdate_11.21.17#Article1
Hartunian, R.S., Wolff, J.C., & Seigel, R. (2018, January). The eight key elements of

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OVERVIEW OF HEALTHCARE COMPLIANCE INTRODUCTION TO HEALTHCARE COMPLIANCE

effective compliance programs. Retrieved from https://www.manatt.com/Insights/


Newsletters/Health-Update/The-Eight-Key-Elements-of-Effective-Compliance-Pro
James, J.T. (2013). A new, evidence-based estimate of patient harms associated
with hospital care. Journal of Patient Safety, 9(3):122-8. doi: 10.1097/
PTS.0b013e3182948a69
National Academy of Sciences. (2017). Global health and the future role of
the United States: A consensus study report of the National Academies of
Sciences•Engineering•Medicine. Washington, DC: The National Academies Press.
Neilsen, M., & Einarsen, S. (2012). Outcomes of exposure to workplace bullying: A
meta-analytic review. Work & Stress: An International Journal of Work, Health &
Organisations, 26, 309-332.
Office of Inspector General. (2011). Health care fraud prevention and enforcement
action team (HEAT) provider compliance training [Presentation]. Washington, DC:
Office of the Inspector General.
Pettinger, T. (2019). Advantages of capitalism. Retrieved from www.economicshelp.org
Probasco, J. (2019). Why do healthcare costs keep rising? Retrieved from www.
investopedia.com
Rodziewicz, T.L., & Hipskind, J.E. (2019). Medical Error Prevention. StatPearls
Publishing LLC.
Safian, S.C. (2009). Essentials of Health Care Compliance. Clifton Park, NY: Delmar,
Cengage Learning.
The Joint Commission. (2019). Official “Do Not Use” List. Retrieved from https://www.
jointcommission.org/facts_about_do_not_use_list/
Thorpe, K. (2011, May 25). Medical advancements: Who is leading the world? HuffPost
News. Retrieved September 27, 2019 from HuffPost.com
United States. Department of Justice. (2018). National health care fraud takedown
results in charges against 601 individuals responsible for over $2 billion in
fraud losses. Retrieved from https://www.justice.gov/opa/pr/national-health-
care-fraud-takedown-results-charges-against-601-individuals-responsible-
over#:~:text=Azar%20III%2C%20announced%20today%20the,than%20%242%20
billion%20in%20false

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2
2.1 LEARNING OBJECTIVES
Ethics and Law

1. Demonstrate a comprehensive overview of health law.


2. Compare and contrast the differences between legal and ethical issues in
healthcare.
3. Describe the role of healthcare enforcement agencies in legal and ethical
situations.
4. Identify the major healthcare laws and regulations that pertain to fraud
and abuse.

2.2 INTRODUCTION
Ethics and law are important topics to consider when thinking about healthcare
compliance. While compliance means following the law, ethics means doing the
right thing even without a law. Many federal and state agencies enforce healthcare
laws and regulations to ensure compliance. Healthcare providers and organizations
must be knowledgeable of industry laws and regulations in order to ensure best
practice and avoid prosecution. In addition, licensing agencies for healthcare
professionals require that professionals follow a code of ethical conduct. This
chapter will explore the major healthcare laws, enforcement agencies, and issues
surrounding ethical behavior relative to compliance in healthcare organizations.

2.3 KEY TERMS


• Ethics
• Laws
• Fraud
• Abuse

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

• Healthcare Laws
• Enforcement Agencies

2.4 ETHICAL CHALLENGES IN HEALTHCARE


Ethics can be defined as the moral principles and set of values that an individual
holds in regards to what is right and what is wrong (Daft, 2016). Four important
principles of ethics guide our actions in healthcare: beneficence, nonmaleficence,
justice, and respect for others. Beneficence refers to a healthcare provider’s
responsibility to do what is in the best interest of others (Olden, 2015). Healthcare
organizations are ethically responsible for doing all they can to alleviate pain and
suffering associated with health care conditions (Shi & Singh, 2015). Nonmaleficence
refers to healthcare providers’ responsibility to do no harm to patients. Since
many health care treatments may present risks to patients, nonmaleficence
requires that the benefits outweigh the risks of medical treatment (Shi & Singh,
2015). The principle of justice refers to fairness and equality, requiring that there
be no discrimination in the delivery of healthcare services (Shi & Singh, 2015).
The principle of respect for others requires that healthcare providers show respect
for the autonomy, privacy, rights, and interests of patients. This means providing
patients with all necessary information required for their making an informed
decision, and allowing patients to make such decisions regarding their own care
without coercion, and obtaining consent for treatment (Shi & Singh, 2015). Four
key aspects of medical ethics are included within the principle of respect for
persons: autonomy, truth-telling, confidentiality, and fidelity. Autonomy refers
to individuals having the right to make their own decisions regarding their care.
Truth-telling refers to providers being honest with patients. Confidentiality refers
to keeping patient information private (Buchbinder & Shanks, 2017). Fidelity refers
to providers performing their duties, keeping their word, and keeping promises
(Shi & Singh, 2015).

Figure 2.1: Four Principles of Ethics


Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Healthcare providers are often faced with situations surrounding ethical


behavior. Ethically challenging situations in healthcare include abortion, artificial
prolongation of life, and physician-assisted suicide (Shi & Singh, 2017). These types
of situations can present a conflict of interest for the provider. A conflict of interest
is a situation in which an individual’s self-interest interferes with that individual’s
obligation to another person or organization (Olden, 2015). These situations often
conflict with a provider’s own morals and values and can cause them immense
distress when determining the most ethical course of action. An individual’s source
of ethics comes from a variety of sources, such as their own personal experiences,
their organization, and their profession. While many healthcare organizations
have a code of ethics that employees must follow, healthcare professionals must
also follow the code of ethics of their professional association (Table 1).

Professional Provider Type Link to Code of Ethics


Association
American Medical Physician https://www.ama-assn.org/delivering-
Association (AMA) care/ethics/code-medical-ethics-
overview
American Nurses Nurse https://www.nursingworld.
Association (ANA) org/~4aef79/globalassets/
docs/ana/ethics/anastatement-
ethicshumanrights-january2017.pdf
American College of Healthcare https://www.ache.org/-/media/ache/
Healthcare Executives Managers, ethics/code_of_ethics_web.
(ACHE) Administrators, and pdf?la=en&hash=F8D67234C06C333
Executives 793BB58402D73741A4ACE3D9D
Table 2.1: Code of Ethics for Healthcare Professional Associations
Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

Real-Life Case: Unethical Behavior

In 2014, Dr. Joseph Darrow, Jr., an orthopedic surgeon, engaged in a sexual


relationship with a patient concurrent with, or immediately following, the
physician-patient relationship and married the patient. The Iowa Board of
Medicine concluded that Dr. Darrow violated the licensing board’s ethical
code of conduct which states that physicians are not allowed to have a sexual
relationship with patients. The case was settled, and the physician agreed to pay
a $5,000 civil penalty (Iowa Board of Medicine, 2014).

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Real-Life Case: Unethical Behavior

In 2016, a Charleston, WV physician, Dr. Iraj Derakhshan, was charged with


violating reporting requirements mandated by federal drug laws for dispensing
controlled substances. Dr. Derakhshan admitted that a patient returned
unused fentanyl, and he illegally dispensed it to another patient. The physician
also admitted he was never authorized to dispense controlled substances. Dr.
Derakhshan permanently surrendered his license for dispensing controlled
substances and was ordered to pay a fine of $10,000.

2.5 LEGAL CONSIDERATIONS


Healthcare laws regulate the provision of healthcare services and govern the
relationship between those who provide care and those who receive care. Laws
are essential rules of conduct that help us determine both our and others’ actions
(Buchbinder & Shanks, 2017). Laws are standards a society considers to be the
minimum principles necessary to keep that society functioning (Judson & Harrison,
2019). An unethical act is not necessarily illegal, but an illegal act by a healthcare
provider is always unethical (Judson & Harrison, 2019). Federal health agencies
design healthcare laws with the goal of protecting the interests and well-being of
the public. Congress provides oversight of healthcare laws and regulations. And
the Department of Health and Human Services (HHS) provides general oversight
in regards to health issues and concerns. The mission of HHS is to “enhance and
protect the health and well-being of all Americans;” this is achieved by “providing
for effective health and human services and fostering advances in medicine, public
health, and social services” (HHS, 2019). Table 2 includes a list of some of the most
influential healthcare laws.

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Law Year Passed Description


The Social Security Act of 1935 1935 The Social Security Act of 1935 was
enacted by Congress and signed
into law by President Franklin D.
Roosevelt. This act established
the Social Security program, an
old-age program funded by payroll
taxes, and insurance against
unemployment.
Medicare 1965 Medicare was enacted by Congress
and signed into law by President
Johnson under the Social Security
Amendments of 1965. The
Medicare program was designed
to provide health care coverage
for individuals over the age of 65.
Since its inception, Medicare has
been expanded to add coverage for
individuals with disabilities and
end-stage renal diseases. Medicare
is administered by the Centers for
Medicare and Medicaid Services
(CMS).
Medicaid 1965 Medicaid was established by
adding Title XIX to the Social
Security Act. Medicaid was
designed to provide health care
coverage for individuals receiving
public assistance, such as low-
income elderly, the blind, or the
disabled. Medicaid has since
been expanded and now includes
low-income children and parents,
pregnant women, the disabled,
and impoverished adults. Medicaid
is administered by the states and
receives a combination of state and
federal funding.
Children’s Health Insurance 1997 CHIP is administered by CMS.
Program (CHIP) CHIP was designed to provide
coverage for children who are not
eligible for Medicaid but whose
parents are unable to afford
private insurance coverage. CHIP
is a state-administered program,
with each state setting their own
eligibility requirements.

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Health Insurance Portability 1996 HIPAA was established to


and Accountability Act of 1996 create guidelines regarding how
(HIPAA) personally identifiable information
should be maintained by healthcare
organizations and to set limitations
on healthcare insurance coverage.
HIPAA was enacted by Congress
and signed into law by President
Clinton.
HIPAA Privacy Rule 2003 The goal of the HIPAA Privacy Rule
is to ensure that an individual’s
health information is properly
protected while not inhibiting the
flow of health information needed
for that individual to receive high
quality care.
HIPAA Security Rule 2005 The HIPAA Security Rule
establishes national standards
for protecting an individual’s
electronic personal health
information and how it is created,
received, used, or maintained.
Patient Safety and Quality 2005 PSQIA establishes a voluntary
Improvement Act of 2005 reporting system which is designed
(PSQIA) to enhance the data available
to assess and resolve patient
safety and health care quality
issues. PSQIA authorizes HHS to
impose civil money penalties for
violations of patient safety and
confidentiality.
Patient Protection and 2010 PPACA is a federal statute that was
Affordable Care Act (PPACA) enacted by Congress and signed
into law by President Obama. The
goal of PPACA was to provide a
regulatory overhaul and expansion
of coverage. The most well-known
provision of the PPACA was the
implementation of an individual
mandate that required individuals
to have health insurance coverage
or they would have to pay a penalty
on their taxes.

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Hospital Readmissions 2012 The HRRP is a Medicare value-


Reduction Program (HRRP) based purchasing program that
reduces payments to hospitals with
excess readmissions. The rate of
readmission is a quality indicator;
thus, this program seeks to
improve the quality of health care
for Americans.
Tax Cuts and Jobs Act of 2017 2017 In regards to its impact on
healthcare, this legislation, enacted
under the Trump administration,
repealed the individual mandate of
the PPACA. This repeal takes effect
in 2019.
Table 2.2: Influential Healthcare Laws
Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

Real-Life Example: HIPAA Violation

In September 2015, Memorial Hermann Health System (MHHS), a hospital health


system serving the Houston, Texas area provided an unauthorized disclosure of
protected health information, which is in violation of the HIPAA Privacy Rule.
A patient that visited an MHHS clinic presented a fraudulent identification card
to hospital staff. The fraudulent ID card was identified by hospital staff which
notified law enforcement, and the patient was arrested. The hospital disclosed
the name of the patient to law enforcement, which is allowable under HIPAA.
However, the hospital then issued a press release about the incident, disclosing
the patient’s name in the title of the press release. Releasing the patient’s name
to the media without permission was an impermissible disclosure of protected
health information. A complaint was filed with the Office of Civil Rights, and
MHHS agreed to a settlement of $2.4 million, in addition to agreeing to adopt
a corrective action plan that requires policies and procedures to be updated and
training staff to prevent further impermissible disclosures of protected health
information.

2.6 ENFORCEMENT
As noted above, a variety of different agencies regulate and govern healthcare
in the U.S. Under Title XXVII of the Public Health Service Act (PHS Act), states
are given the responsibility of exercising primary enforcement over health insurers
to ensure they comply with health insurance market forms (CMS, Compliance
and Enforcement, 2019). The HHS Office for Civil Rights holds the responsibility

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

for enforcing the HIPAA Privacy and Security Rules (HHS, HIPAA Enforcement,
2019). Key healthcare enforcement agencies and their responsibilities are listed in
Table 3.

Agency Description
Agency for Healthcare Research and The primary function of AHRQ is to support
Quality (AHRQ) research designed to improve health care
quality and outcomes, reduce costs, address
patient safety and medical errors, and improve
access to health care.
Agency for Toxic Substances and The mission of ATSDR is to prevent exposure
Disease Registry (ATSDR) and adverse human health effects and
diminished quality of life associated with
exposure to hazardous substances from waste
sites, unplanned releases, and other sources of
pollution present in the environment.
Centers for Disease Control (CDC) The mission of the CDC is to promote health
and quality of life by preventing and controlling
disease, injury, and disability. The CDC works
with national and international partners to
monitor health, detect and investigate health
problems, conduct research to enhance
prevention, develop and advocate sound
public health policies, implement prevention
strategies, promote healthy behaviors, foster
safe and healthful environments, and provide
leadership and training.
Department of Health and Human OCR is responsible for enforcing HIPAA rules
Services Office for Civil Rights (OCR) and regulations.
Food and Drug Administration (FDA) The FDA ensures the safety of foods and
cosmetics and the safety and efficacy of
pharmaceuticals, biological products, and
medical devices. Its employees monitor the
manufacture, import, transport, storage, and
sale of about $1 trillion worth of products each
year.
Health Resources and Services The HRSA directs national health programs
Administration (HRSA) that improve the nation’s health by assuring
equitable access to comprehensive, quality
health care for all. HRSA also works to improve
and extend life for people living with HIV/
AIDS, provide primary health care to medically
underserved people, serve women and children
through state programs, and train a health
workforce that is both diverse and motivated to
work in underserved communities.

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Centers for Medicare and Medicaid CMS administers the Medicare and Medicaid
Services (CMS) programs, in addition to other major programs
such as the State Children’s Health Insurance
Program (SCHIP); the Medicare Prescription
Drug, Improvement, and Modernization Act
(MMA); and the Health Insurance Portability
and Accountability Act (HIPAA). The mission
of CMS is to ensure healthcare security for its
beneficiaries.
Indian Health Services (IHS) IHS provides comprehensive healthcare
services, including preventive, curative,
rehabilitative, and environmental care for
American Indians and Alaska Natives who
belong to more than 550 federally recognized
tribes in 35 states.
National Institutes of Health (NIH) NIH, the Nation’s medical research agency, is
composed of 27 Institutes and Centers. NIH
provides leadership and financial support to
researchers in every state, and throughout
the world, helping to lead the way toward
important medical discoveries that improve
people’s health and save lives.
Office of the National Coordinator for ONC is responsible for coordinating nationwide
Health IT (ONC) efforts to implement and use health information
technology. This includes implementation of
initiatives, such as electronic health record
(EHR) adoption.
Substance Abuse and Mental Health SAMHSA works to improve the quality and
Services Administration (SAMHSA) availability of prevention, treatment, and
rehabilitative services in order to reduce illness,
death, disability, and cost to society resulting
from substance abuse and mental illnesses.
Table 2.3: Key Healthcare Enforcement Agencies (USPHS, 2019)
Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

2.7 FRAUD AND ABUSE


Fraud and abuse have always been areas of concern in healthcare. In particular,
Medicare and Medicaid experience a high prevalence of fraud and abuse (Shi &
Singh, 2017). Fraud has been defined as “an intentional act of deception,” while
abuse has been defined as “improper acts that are unintentional but inconsistent
with standard practices” (Buchbinder & Shanks, 2017, p. 442). Abuse is considered
to be an unintentional mistreatment, while fraud constitutes an intentional act.
Examples of fraud and abuse in healthcare include billing for services not provided,
billing for services that are not medically necessary, submitting duplicate bills, and

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

improperly using codes to receive higher reimbursement (Buchbinder & Shanks,


2017). Several laws and regulations have been established to specifically address
fraud and abuse (Table 4).

Law Year Passed Description Penalties


False Claims Act 1863 The False Claims Act imposes No less than $5,000 or more
liability on any person who than $10,000, plus potential
knowingly submits or causes damages, for each false claim
the submission of false or filed.
fraudulent claims for payment
or approval.
Anti-Kickback 1972 The Anti-Kickback Statute Up to $25,000 per violation,
Statute prohibits providers of services felony conviction punishable
covered by a Federal healthcare by imprisonment up to 5
program from receiving years, or both, as well as
anything of value in order possible exclusion from
to induce or reward patient participation in Federal
referrals. Healthcare Programs.
Stark Law 1989 The Stark Law prohibits the Up to $15,000 for each claim
referral of Medicare and submitted in violation of the
Medicaid beneficiaries by a statute.
physician to an entity in which
the physician has a financial
relationship.
Exclusion 1999 Under Section 1128 of the Up to $10,000 per item
Provisions Social Security Act, the HHS or service claimed while
Office of Inspector General excluded. HHS may also
(OIG) has authority to exclude impose an assessment of up
individuals from participating to three times the amount
in federal health care programs claimed.
for various reasons, such
as program-related crimes,
convictions related to patient
abuse, felony convictions
related to health care fraud, and
felony convictions related to
controlled substances.
Civil Monetary 2001 The Civil Monetary Penalties Range from $10,000 to
Penalties Law Law, Section 1128A of the Social $50,000 per violation.
Security Act, authorizes HHS-
OIG to impose civil penalties for
violations of the Anti-Kickback
Statute and other related
violations.
Table 2.4: Laws & Regulations Related to Fraud & Abuse
Source: Original Work
Attribution: Lesley Clack
Source: CC BY-SA 4.0

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Real-Life Example: False Claims Act, Stark Law, and Anti-


Kickback Statute Violation

Amedisys, one of the country’s largest providers of home health services, based
in Baton Rouge, Louisiana, and its affiliates agreed to pay $150 million to resolve
allegations brought under the False Claims Act, Stark Law and the Anti-Kickback
Statute. The lawsuit filed against Amedisys was brought under the qui tam, or
whistle-blower, provision of the False Claims Act by former employees of the
company. The lawsuit alleged Amedisys submitted improper claims to Medicare
for reimbursement from 2008 to 2010 for therapy and nursing services that were
medically unnecessary or provided to patients who were not homebound. The
lawsuit also alleged the company engaged in improper financial relationships
with referring physicians.

2.8 IMPLICATIONS FOR COMPLIANCE


The many healthcare codes of ethics, laws, and regulations we’ve discussed
serve as a source of compliance in healthcare. OIG recommends that organizations
adopt a corporate compliance plan which assist in ensuring the organization
complies with all laws and regulations and seeks to reduce risk of errors or
omission (Buchbinder & Shanks, 2017). The OIG provides a list of elements that
are considered essential for any compliance program (OIG, 2017):

• Element 1: Standards, Policies, and Procedures


• Element 2: Compliance Program Administration
• Element 3: Screening and Evaluation of Employees, Physicians,
Vendors and other Agents
• Element 4: Communication, Education, and Training on Compliance
Issues
• Element 5: Monitoring, Auditing, and Internal Reporting Systems
• Element 6: Discipline for Non-Compliance
• Element 7: Investigations and Remedial Measures

Healthcare organizations must ensure compliance with all laws and regulations,
and a corporate compliance program is instrumental in meeting this objective.

2.9 SUMMARY
Governance of healthcare delivery comes from a wide variety of sources, such
as ethical codes of conduct, healthcare laws and regulations, and enforcement
agencies. Protecting patients is the utmost concern, which is one of the reasons
that healthcare is such a highly regulated industry. With the healthcare landscape

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

constantly changing, and new laws and regulations continually added over time, it
is vital that healthcare providers and organizations stay up to date. Good corporate
compliance is essential when dealing with law and ethics in the healthcare industry.

2.10 DISCUSSION QUESTIONS


1. Find a recent case in the media regarding the violation of a healthcare
law. Which law is addressed in the case? What were the main issues in
the case? Did the plaintiff win their case? Why or why not?
2. Think of an example of unethical behavior that you have heard of or have
observed in healthcare. Which of the four ethical principles were violated
in this situation? If you were a manager, how would you deal with this
behavior? Is the behavior only unethical, or is it also illegal? If so, which
healthcare law is also violated in the situation?
3. An administrator at the hospital you work for has ordered all physicians
to use codes with the highest reimbursement rates. A physician in the
emergency room has billed for services that were not provided. Is this
fraud or abuse? What should the hospital do?
4. You are an administrator for a home health agency. Write a brief
compliance plan using the OIG’s seven essential elements for a
compliance plan.

2.11 KEY TERM DEFINITIONS


1. Ethics—the moral principles and set of values that an individual holds in
regards to what is right and what is wrong.
2. Laws—essential rules of conduct that help us determine our actions
and others’ actions and are considered to be the minimum principles
necessary to keep society functioning.
3. Fraud—an intentional act of deception.
4. Abuse—improper acts that are unintentional but inconsistent with
standard practices.
5. Healthcare Laws—regulate the provision of healthcare services and
govern the relationship between those who provide care and those who
receive care.
6. Enforcement Agencies—agencies that regulate and govern health
care in the U.S.

2.12 REFERENCES
Buchbinder, S.B. & Shanks, N.H. (2017). Introduction to Health Care Management, 3rd
edition.

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OVERVIEW OF HEALTHCARE COMPLIANCE ETHICS AND L AW

Burlington, MA: Jones & Bartlett Learning.


Centers for Medicare and Medicaid Services. (2019). Compliance and Enforcement.
Retrieved from https://www.cms.gov/cciio/programs-and-initiatives/health-
insurance-market-reforms/compliance.html
Daft, R.L. (2016). Organization Theory and Design, 12th edition. Boston, MA: Cengage
Learning.
Department of Health and Human Services (HHS). (2019). About HHS. Retrieved from
https://www.hhs.gov/about/index.html
Department of Health and Human Services (HHS). (2019). HIPAA Enforcement.
Retrieved from https://www.hhs.gov/hipaa/for-professionals/compliance-
enforcement/index.html
Iowa Board of Medicine. (2014). In the Matter of Statement Charges Against Joseph C.
Darrow, Jr., M.D., Respondent. Retrieved from https://medicalboard.iowa.gov/sites/
default/files/documents/2018/04/darrowjosephc.jr_.m.d.-02-2014-468.pdf
Judson, K. & Harrison, C. (2019). Law & Ethics for Health Professions, 8th edition. New
York, NY: McGraw-Hill Education.
Measuring Compliance Program Effectiveness: A Resource Guide. Retrieved from
https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf
Office of the Inspector General (OIG), Department of Health and Human Services. (2017).
Olden, P.C. (2015). Management of Healthcare Organizations: An Introduction.
Chicago, IL: Health Administration Press.
Shi, L. & Singh, D.A. (2015). Delivering Health Care in America: A Systems Approach.
Burlington, MA: Jones & Bartlett Learning.
Shi, L. & Singh, D.A. (2017). Essentials of the U.S. Health Care System, 4th edition.
Burlington, MA: Jones & Bartlett Learning.
US Public Health Service (USPHS). (2019). HHS Offices and Agencies. Retrieved from
https://www.usphs.gov/aboutus/agencies/hhs.aspx

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3
3.1 LEARNING OBJECTIVES
Health Insurance &
Reimbursement

1. Identify innovative new approaches to the payer/provider model.


2. Differentiate between the types of health insurance.
3. Analyze the laws that govern health insurance & reimbursement
practices.
4. Describe the effects of noncompliance with reimbursement practices.

3.2 INTRODUCTION
Various United States insurance plans include government based and
private payers. When these payers fail to adhere to reporting requirements for
reimbursement, results can include losses in revenue, penalties, fines, and a
revocation of business licenses. This chapter will discuss the types of insurance
plans currently available, innovative approaches to the established payer/
provider model, and standard reimbursement practices. The laws that govern
health insurance and reimbursement practices will be examined and the effects of
noncompliance reviewed.

3.3 KEY TERMS


• Accountable Care Organizations (ACOs)
• Electronic Health Record (EHR)
• Federal Poverty Level (FPL)
• Fee-for-service (FFS)
• Health Maintenance Organization (HMO)
• Preferred Provider Organizations (PPO)
• Primary Care Physician (PCP)

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

3.4 HISTORICAL EVOLUTION OF PAYER MODELS


Prior to the 1900s, health insurance as we know it today did not exist in
the United States. However, employers such as railroad companies did develop
“hospital associations” where employees could receive health care from physicians
who were employed by the railroad company (Kongstvedt, 2020). Trade unions
also offered employees they represented financial protection in case they became
ill or injured. Kaiser, one of today’s most well-known names in health care and
insurance, initially began as a construction company that offered coverage for their
employees (this plan would later become known as the Kaiser Health Plan).
By the mid 1800’s, several companies offered commercial and/or group health
insurance programs. However, these companies were not financially successful
because they attracted large numbers of sick individuals and did not charge
premiums sufficient to cover their expenses. Although the insurance industry was
beginning to expand, the policies offered were not the same as modern day health
insurance.
Prior to World War II (WWII), only 10% of patients had any type of health
benefits, thus most patients paid for any health services they received out of pocket
(Kongstvedt, 2020). By the mid-1950s, however, almost 70% of patients had health
benefits. Several reasons account for this increase in health coverage, such as the
following:

• Individuals were driven to obtain health benefits to allow for improved


and affordable health care;
• Physicians sought ways to generate steady, reliable revenue;
• Employers offered health benefits as a means to recruit and retain
employees;
• Lending agencies encouraged their clients to obtain health benefits to
reduce the number of foreclosures that occurred due to health-related
personal bankruptcies (Kongstvedt, 2020).

In addition to these incentives, one additional factor influenced Americans


to obtain health benefits. Due to the scarcity of physical resources and available
workforce after WWII, the U.S. government passed the 1942 Stabilization Act. The
act prevented employers from paying higher wages to attract workers. However,
the act did allow for certain employer contributions (including health benefits)
to be non-taxable. As a result, workers were motivated to obtain employer-based
health benefits to offset their taxable income.
Two health benefit models were available during this time: health maintenance
organizations (HMOs) and Blue Cross and Blue Shield plans. HMOs charge a set
fee per person/enrollee who must receive care from one of the HMO’s facilities
and providers (commonly referred to as in-network facilities and providers). Blue
Cross and Blue Shield (BC/BS) plans contracted with healthcare facilities and

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

providers in the community and allowed their members to obtain care at any of the
covered sites. However, BC/BS plans were prepaid benefits, not health insurance
as we know it today. These two models were the precursors of today’s HMOs and
Preferred Provider Organizations (PPOs).

Figure 3.1: HMO & PPO Comparison Chart


Source: Medical Mutual of Ohio ®
Attribution: Medical Mutual of Ohio ®
License: © Medical Mutual of Ohio ®. Used with permission.

HMOs later transformed their structure to one referred to as an independent


practice association (IPA) (Kongstvedt, 2020). In contrast to the previous structure,
which was composed of HMOs with their own dedicated medical staff and facilities,
the newly formed IPAs included contracts with independent physicians or with
organizations who contract with physicians.

Figure 3.2: HMO Flowchart


Source: Original Work
Attribution: Corey Parson
License: CC BY-SA 4.0

Medicare was established in 1965 by Title XVIII of the Social Security Act,
beginning with Medicare Part A which covers hospital services, and Medicare Part
B which covers physicians’ services (Klees, Wolfe, & Curtis, 2009). Part A was

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

funded through taxes on earned income while Part B was funded through premiums
and general revenues (Kongstvedt, 2020). Medicare was initially offered to those
individuals who were age 65 or over. However, additional groups were later added,
including individuals who are:

• Entitled to Social Security or Railroad Retirement disability for at least


24 months;
• Diagnosed with certain illnesses such as end-stage renal disease
(ESRD);
• Otherwise not eligible but elect to pay a premium.

Figure 3.3: Medicare Parts A & B Coverage


Source: Original Work
Attribution: Larecia Gill
License: CC BY-SA 4.0

In 1997, the Balanced Budget Act (BBA) established the Medicare+Choice


program, otherwise referred to as Medicare Part C or the Medicare Advantage
Program. This program was modified and renamed in 2003 as the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA) which expanded
recipients’ options in private-sector health plans (Klees, Wolfe, & Curtis, 2009).
The MMA also added Medicare Part D, which provides prescription drug coverage.
As the program has continued, there have been changes to the coverage,
premium, and age of eligibility. For example, beneficiaries with higher incomes
pay a higher premium for Part B and prescription drug coverage (Social Security
Administration, 2019). The monthly Medicare Part B premiums for 2019 are listed
in table 3.1:

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

Modified Adjusted Part B Monthly Prescription Drug


Gross Income Premium Amount Coverage Monthly
(MAGI) Premium Amount
Individuals with a MAGI of 2019 standard premium Your plan premium
$85,000 or less, married = $135.50
couples with a MAGI of
$170,000 or less
Individuals with a MAGI Standard premium + Your plan premium +
above $85,000 and up to $54.10 $12.40
$107,000, married couples
with a MAGI above $170,000
and up to $214,000
Individuals with a MAGI Standard premium + Your plan premium +
above $107,000 and up to $135.40 $31.90
$133,500, married couples
with a MAGI above $214,000
and up to $267,000
Individuals with a MAGI Standard premium + Your plan premium +
above $133,500 and up to $216.70 $51.40
$160,000, married couples
with a MAGI above $267,000
and up to $320,000
Individuals with a MAGI Standard premium + Your plan premium +
above $160,000 and up to $297.90 $70.90
$500,000, married couples
with a MAGI above $320,000
and up to $750,000
Individuals with a MAGI Standard premium + Your plan premium +
equal to or above $500,000, $325.00 $77.40
married couples with a MAGI
equal to or above $750,000
Table 3.1: The standard Part B premium for 2019 is $135.50. If you’re single and filed
an individual tax return, or married and filed a joint tax return, the following applies to
you:
Source: Social Security Administration
Attribution: Social Security Administration
License: Public Domain

Title XIX of the Social Security Act established Medicaid, which is a program
jointly funded by the federal and state governments to provide medical care for
individuals with low incomes (Klees, Wolfe, & Curtis, 2009). Within federal
guidelines, each state establishes eligibility criteria, authorized services, and
reimbursement rates. Therefore, individuals who may qualify for Medicaid benefits
in one state may not be eligible in other states. Although each state determines the
eligibility criteria, all must include the following requirements for applicants:

• Be a resident of the state for which they are applying for coverage;

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

• Be a citizen of the United States or a member of certain qualified non-


citizen groups such as lawful permanent residents;
• Meet set modified adjusted gross income (MAGI) levels;
• Include children who are covered by the adoption assistance agreement
under Title IV-E of the Social Security Act.

States may opt to include individuals deemed “medically needy” whose financial
status is too high to qualify for Medicaid (Centers for Medicare & Medicaid Services,
2019, Medicaid Eligibility).
Title XXI of the Social Security Act established the Children’s Health Insurance
Program (CHIP; formerly referred to as State Children’s Health Insurance Program
or SCHIP). This program provides funding for health coverage for children who are
from low-income households but do not qualify for Medicaid. These children would
generally be uninsured without the availability of CHIP. Each state establishes
eligibility criteria for CHIP (see figure 3.4).

Figure 3.4: Income Eligibility Levels for Children in Medicaid/CHIP, January 2019
Source: Kaiser Family Foundation
Attribution: Kaiser Family Foundation
License: © Kaiser Family Foundation. Used with permission.

3.5 TYPES OF INSURANCE


Three distinct markets offer health insurance plans: coverage purchased by
individuals, group coverage offered by employers and paid for by employer and

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

employee premiums, and governmental entitlement programs (Kongstvedt,


2020). Medicare and Medicaid are both examples of government payer insurance
plans. In general, there are two major types of private payer insurance in the U.S.:
traditional (indemnity) and managed care.

3.5.1 Traditional Health Insurance


Fee-for-service, sometimes referred to as indemnity coverage, is a type of
insurance plan that provides members with autonomy in choosing physicians
and where they receive care, and does not require referrals to specialists (Altman,
Cutler, & Zeckhauser, 2000). However, out of pocket expenses are usually higher—
including deductibles, which may range from $200-$2,500 (Medical Mutual of
Ohio, 2019). Fee-for-service plans were the most common health plans available
in the U.S. until managed care plans became more popular.

3.5.2 Managed Care Plans


Managed care plans are currently the most common insurance programs
offered in the U.S. These types of plans focus on two aspects of health care: cost
and quality. Managed care plans contract with select healthcare providers and
organizations to provide services to members at a reduced cost. In addition, these
plans focus on preventative health care to improve members’ overall health, thus
decreasing costs. Other cost-saving incentives include offering generic medications
at a reduced price compared to brand. HMOs are one example of a managed care
plan. In addition to HMOs, other types of managed care plans include:

• Preferred provider organizations (PPOs): these health plans have a


network of physicians, hospitals, and specialists who provide care
for members enrolled in the PPO for reduced fees. Unlike an HMO,
members do not have to obtain a referral from their primary healthcare
provider to see a specialist. Members may choose to see providers who
are in or out of network; however, if they select an in-network provider,
their cost will be less.
• Point-of-service (POS) plans: a mixture of an HMO and PPO; members
are usually required to select a primary healthcare provider and obtain
referrals to specialists. Costs will be less if members use an in-network
provider.
• High deductible health plans (HDHPs): as the name infers, these plans
have higher deductibles than other plans, but the monthly premium is
lower. The deductible must be paid by the member before insurance
will pay for treatment. Therefore, members of these plans pay less each
month in premiums but have higher out-of-pocket expenses when
receiving medical care.

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

Figure 3.5: HMO vs. PPO


Source: Original Work
Attribution: Corey Parson
License: CC BY-SA 4.0

Figure 3.6: Percentage of Covered Workers by Type of Plan


Source: Kaiser Family Foundation
Attribution: Claxton, Rae, Long, Panchal, & Damico
License: © Kaiser Family Foundation. Used with permission.

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

3.6 INNOVATIVE NEW APPROACHES TO THE


PAYER/PROVIDER MODEL
Traditional (indemnity) plans were the predominant form of insurance
until the 1980s when managed care plans were introduced. Traditional plans
allowed their members to receive care from any provider and/or healthcare
facility with payments based on the care received (fee-for-service). However, this
reimbursement structure led to rapid increases in medical costs after providers
realized they could increase their revenue by expanding the number of patients
healthcare providers treated and ordering more procedures. Health insurance
companies countered by increasing patients’ cost-shares by raising the amount
required for plan deductibles and patient co-payments (Kjesten).
As a result of high insurance costs, many Americans could not afford to
purchase health insurance, leading to 44 million uninsured residents by 2013. To
combat this issue, President Barack Obama (2008 – 2016) passed a healthcare
reform bill, which included the Affordable Care Act (ACA), and the new program
began enrollment in fall 2013 (Glied, Ma, Borja, 2017). Included in the ACA,
Medicaid coverage was expanded to cover nonelderly adults with incomes below
138 percent of the federal poverty level (FPL) and offered tax credits for individuals
with incomes between 100—400% of the FPL. The ACA extended health insurance
via a health care marketplace which catered to individuals and small employers
and eliminated any pre-existing condition clauses (Garfield, Orgera, Kaiser Family
Foundation, & Damico, 2019). The ACA also extended healthcare coverage for
children up to age 26 years. As a result, the number of uninsured individuals in the
U.S. has fallen from 44 million to 27 million.

Figure 3.7: Affordable Care Act Coverage Gains Driving Uninsured Rate to Historic Low.
(This material was created by the Center on Budget and Policy Priorities (www.cbpp.org))
Source: Center on Budget and Policy Priorities
Attribution: Center on Budget and Policy Priorities
License: © Center on Budget and Policy Priorities. Used with permission.

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

In response to high insurance costs, and in an effort to improve consumer health


while controlling costs, insurance companies have developed new, innovative
healthcare models that include accountable care organizations (ACOs), Medicare
Shared Savings Programs (also referred to as the Patient Centered Medical Home
Model, PCMH), and Alternative Quality Contracts (Chernew, Mechanic, Landon,
& Safran, 2011; National Committee for Quality Assurance (NCQA), 2019). These
models are focused on the quality of care beneficiaries receive rather than the
quantity of services. ACOs include groups of physicians, healthcare organizations,
and other providers who work together to provide comprehensive, high-quality
care to Medicare patients (Centers for Medicare & Medicaid Services, 2019; ACOs).
In exchange for meeting pre-set quality indicators, providers are given financial
incentives.
As a result of increased access to health care, as well as medical breakthroughs,
Americans are living longer with multiple comorbidities. Due to the complex
health needs of an aging population, Medicare recipients often receive care from
multiple providers in a variety of settings, and commonly require social and
behavioral health care support (Lipson, Rich, Libersky, & Parchman, 2011). The
development of the PCMH model addressed these needs by improving beneficiary
health through coordinated efforts, enhanced communication between providers
and settings, and improved management of chronic health conditions (NCQA,
2019). PCMH models are comprised of five elements:

• Patient-centered orientation toward each patient’s unique needs,


culture, values, and preferences; support of the patient’s self-care
efforts; and involvement of the patient in care plans.
• Comprehensive, team-based care that meets the majority of each
patient’s physical and mental health care needs, including prevention
and wellness, acute care, and chronic care which are provided by a
cohesive team.
• Care that is coordinated across all elements of a complex healthcare
system and connects patients to both medical and social resources in
the community.
• Superb access to care that matches patients’ needs and preferences,
including care provided after hours and alternative methods of
communication such as email and telephone.
• A systems-based approach to quality and safety that includes gathering
and responding to patient experience data, committing to ongoing
quality improvement, and practicing population health management
(Lipson, Rich, Libersky, & Parchman, 2011).

For healthcare providers, the benefits of PCMH include improved efficiency and
reimbursement support, and lower practice costs (NCQA, 2019).

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

A third type of healthcare model, alternate quality contracts, addresses the


shortcomings of the fee-for-service model by providing healthcare providers
with an annual budget for providing care to members, and significant financial
incentives for meeting pre-set clinical performance targets (Chernew, Mechanic,
Landon, & Safran, 2011). Alternate quality contracts last for a period of five years
to provide healthcare providers ample time to meet the clinical targets.

3.7 HEALTH INSURANCE RELATED LAWS AND


REGULATIONS
Beginning with the McCarran-Ferguson Act, states were granted the authority
to oversee health insurance related products (Kongstvedt, 2020). States have
historically regulated issues such as:

• Establishing solvency requirements;


• Requiring coverage for certain medical conditions;
• Establishing requirements for healthcare provider networks;
• Setting standards for medical claim reviews;
• Developing standards for licensing managed care organizations and
insurance agents;
• Other consumer protections, such as laws protecting the privacy of
health information. (page 232 -233)

However, in 1973 Congress passed the HMO Act which established federal
regulatory agency roles and jurisdiction in overseeing managed care policies.
Examples of federal laws related to health care include the Affordable Care Act
(ACA) and Social Security Act (SSA). Other noteworthy laws include the:

• Employee Retirement Income Security Act of 1974 (ERISA): ERISA


was established to set minimum standards for retirement and health
plans offered in private industry to provide protection for consumers
(U.S. Department of Labor, n.d.). ERISA regulates and sets standards
for conduct, reporting and accountability, disclosures, procedural
safeguards, and financial and best-interest protection.
• Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985:
COBRA was enacted as an amendment to the ERISA law. This law
requires employers with 20 or more employees to offer employees and
their families continuing group insurance coverage for limited periods
of time during circumstances when coverage would usually end,
including:
◊ Voluntary or involuntary job loss;

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◊ Reduction in hours worked;


◊ Transition between jobs;
◊ Death, divorce, and other life events (U.S. Department of Labor,
n.d.).
Individuals who qualify for COBRA may be required to pay the entire
cost of the premium — up to 102 percent of the cost of the plan. If
employees cannot afford (or choose not to obtain) COBRA insurance,
they may choose to enroll in private health insurance which can be
found in the health insurance marketplace.
• Health Insurance Portability and Accountability Act (HIPAA) of 1996:
HIPAA is another amendment to ERISA and is most well-known for
the protections it offers for personal health information held by covered
entities (Heathfield, 2019). This protection extends to patients’ and
employees’ health information. Covered entities include:
◊ Health plans (including health insurance companies, HMOs,
company health plans) and certain governmental plans such as
Medicare and Medicaid;
◊ Most health care providers, including most physicians, clinics,
hospitals, psychologists, chiropractors, nursing homes, pharmacies,
and dentists;
◊ Health care clearinghouses – organizations that process health
information from other organizations into a standard (i.e., standard
electronic format or data content);
◊ Business associates—includes individuals or entities who are
not employees of the covered entity, including contractors and
subcontractors who handle billing practices or process health
care claims; companies who administer health plans; lawyers;
accountants; IT specialists; and companies that store or destroy
medical records (Office for Civil Rights, 2017).

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A Covered Entity is one of the following:

A Health Care A Health Plan A Health Care


Provider Clearinghouse

This includes providers This includes: This includes entities


such as: that process nonstandard
• Health insurance
• Doctors health information they
companies
receive from another
• Clinics • HMOs entity into a standard
• Psychologists • Company health plans (i.e., standard electronic
format or data content) or
• Dentists • Government
vice versa.
• Chiropractors programs that pay for
health care, such as
• Nursing homes Medicare, Medicaid,
• Pharmacies, and the military and
but only if they veteran health care
transmit any programs.
information in an
electronic form
in connection
with a transaction
for which HHS
has adopted a
standard.
Table 3.2
Source: U.S. Department of Health and Human Services
Attribution: U.S. Department of Health and Human Services
License: Public Domain

However, HIPAA also mandates that group plans limit exclusions for
preexisting conditions, prohibits discrimination against employees
and dependents based on health status, and allows individuals the
opportunity to enroll in an individual health insurance plan if a group
insurance plan is not available and the individual has exhausted
COBRA coverage.

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Figure 3.8: Who Must Comply with HIPAA


Source: iStock
Attribution: iStock
License: © iStock. Used with permission.

• Tax Equity and Fiscal Responsibility Act (TEFRA) of 1982: This act
allowed states to offer medical assistance to certain children with
disabilities who would otherwise not qualify for coverage. Eligibility is
not based on parent income and is available to noncitizen children who
meet all of the following:
◊ Under 19 years old;
◊ Live with at least one biological or adoptive parent;
◊ Certified as disabled;
◊ Requires the level of care provided by:
▪ A hospital,
▪ A nursing home, or
▪ An intermediate care facility for persons with mental
retardation and related conditions
◊ Has an income under 100% of the federal poverty guideline (FPG)
for a household size of one (Department of Human Services, 2017).

3.8 OVERSIGHT AND REGULATION OF


REIMBURSEMENT PRACTICES
There are two major types of payment practices available: risk-based and non-
risk-based. Risk-based payment programs share some portion of financial risk for
medical costs with the provider (Kongstvedt, 2020). This method ensures that
the financial goals of the provider align with those of the payer and/or employer

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which helps contain medical costs. In contrast, non-risk-based payment methods


do not align the provider’s financial goals with the payer and/or employer, but
rather reimburses providers a higher payment in correlation with higher costs/
fees. All types of payer practices may choose to participate in non-risk-based
payment methods (and most do); however, only HMOs may choose to use risk-
based payment methods.
A third type of reimbursement plan is the value-based payment (VBP)
program, which bases reimbursement on both costs and quality (or outcomes)
and usually involves non-risk-based payment methods that are modified. VBP is
less common than other types of reimbursement methods because it is vaguely
defined, with some plans focusing mostly on costs OR quality, with no standard
definitions or methods in place (Kongstvedt, 2020). One exception is the Medicare
fee-for-service (FFS) program.
In an effort to oversee healthcare and reimbursement practices, the federal
government has developed regulatory agencies dedicated to this task. In addition,
states provide their own agencies to investigate and combat fraud and abuse
(Safian, 2009). Listed below are several of the major agencies, along with their
roles in health care:

• Centers for Medicare and Medicaid Services (CMS) is an organization


within the Department of Health and Human Services (DHHS) that
is responsible for regulating Medicare, Medicaid, and the Children’s
Health Insurance Program (CHIP);
• Comprehensive Error Rate Testing (CERT) was created by CMS to
collect data regarding the error rate for claims that were erroneously
paid to providers;
• Durable Medical Equipment Regional Carriers (DMERC) regulate and
process claims for durable medical equipment (DME) applied for by
Medicare beneficiaries;
• Federal Bureau of Investigation (FBI) focuses on investigating both
organizations and individuals suspected of defrauding healthcare
systems;
• Hospital Payment Monitoring Program (HPMP) is another
organization established by CMS to collect data regarding the error rate
for Medicare claims erroneously approved by Quality Improvement
Organizations (QIOs);
• Joint Commission is an agency that accredits health care organizations
that meet quality and safety of care standards; accreditation is one
measure used to qualify facilities to participate in programs such as
Medicare and Medicaid;
• Medicaid Fraud Control Units (MFCU) are state-run organizations
that investigate and prosecute individuals suspected of defrauding

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Medicaid, and/or abusing and neglecting patients who receive


Medicaid. States receive federal grant money through the Medicare and
Medicaid Anti-Fraud and Abuse Amendments of 1997 to operate these
agencies.
• Office of Civil Rights (OCR) is an organization within the Department of
Health and Human Services that oversees compliance with HIPAA and
investigates and prosecutes violations;
• U.S. Department of Justice (DOJ) developed the National Procurement
Fraud Task Force to oversee the prevention, detection, and prosecution
of procurement fraud (Safian, 2009, pgs. 58-61).

3.9 REGULATORY STATUTES AND PROGRAMS


This section will introduce you to the current laws that are in place to regulate
reimbursement practices. It is impossible to include all applicable laws due to
the variety of clinical settings in which care is provided. Further, some laws may
pertain to certain practice settings but not others. Therefore, only key legislation
will be included for review.

• Emergency Medical Treatment and Active Labor Act (EMTALA) was


passed in 1986 to ensure that any facility that cares for Medicare
patients and provides emergency services will provide medical
assessments and/or treatments to stabilize patients in need of emergent
care without regard to the patient’s ability to pay. Facilities and/or
providers found to have violated EMTALA are subject to penalties
including termination of the entity’s Medicare provider agreement;
hospital fines up to $50,000 per violation ($25,000 for hospitals with
less than 100 beds); and physician fines of $50,000 per violation. In
addition, hospitals may be sued in civil court, and the receiving facility
may sue for financial loss related to the other hospital’s violation of
EMTALA (American College of Emergency Physicians, 2019).
• Federal False Claims Act makes it illegal for anyone to “knowingly
submit a false claim to the government or cause another to submit
a false claim to the government or knowingly make a false record or
statement to get a false claim paid by the government…the reverse false
claims section provides liability where one acts improperly – not to
get money from the government, but to avoid having to pay money to
the government” (DOJ, 2011). According to the FCA, it is not illegal to
simply submit a false claim to the government in error; it is illegal to
knowingly submit (or cause the submission of) a false claim. Penalties
for violating the FCA include fines up to three times the claim amount,
plus $11,000 per claim filed. Those individuals found to be in violation

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are also subject to criminal prosecution and incarceration of up to five


years (CMS, Laws, 2015).
• In addition to regulating privacy laws regarding individual and
employee health information, HIPAA also mandates the use of
diagnostic and procedure codes for reimbursement practices (CMS,
2019). These code sets classify medical diagnoses, procedures,
diagnostic tests, treatments, equipment, and supplies.

Code Set Type of Usage


Current procedural Procedure or type of service by physicians and other
terminology, fourth revision providers for inpatient and outpatient care.
(CPT – 4)
Healthcare common procedural Codes used by many different types of providers.
coding system (HCPCS) Level 1 codes and CPT – 4, Level 2 codes are for
ambulance, equipment, supplies, and so forth for
which there are no CPT – 4 codes.
International classification of Used to report diagnoses in all clinical settings. ICD
diseases, 10th edition, clinical – 10 replaces Volumes 1 and 2 of ICD – 9 – CM, and
modification (ICD – 10) ICD – 10 – PCS replaces Volume 3.
National drug codes (NDC) Used for drugs and biologics.
Code on dental procedures and Used for dental procedures and services.
nomenclature (CDT)
Table 3.3: Standardized Code Sets Mandated by HIPAA
Source: Centers for Medicare and Medicaid Services
Attribution: Centers for Medicare and Medicaid Services
License: Public Domain

Approval for reimbursement, along with the amount of reimbursement,


is affected by the code used for billing. Penalties for HIPAA violations
range from fines to criminal charges and incarceration up to 10 years.
Fines may range from $25,000 per violation category to $1.5 million
per violation category.

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Figure 3.9: HIPAA Privacy Violation by Types


Source: Original Work
Attribution: Larecia Gill
License: CC BY-SA 4.0

Figure 3.10: HIPAA Violation Penalties


Source: HIPAA Journal
Attribution: HIPAA Journal
License: © HIPAA Journal. Used with permission.

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• Health Care Fraud and Abuse Control Program (HCFACP) was


developed under the auspices of the Office of Inspector General (OIG)
and the Department of Justice by HIPAA in an effort to coordinate
federal, state, and local law enforcement activities in addressing health
care fraud and abuse (U.S. Department of Health and Human Services,
Office of Inspector General, 2019).
• The Physician Self-Referral Act – Stark I, II, and III, otherwise
known as the Stark Law, specifies conditions under which a provider
cannot refer a patient to another facility; specifically, the provider
cannot refer patients to other facilities or organizations in which the
referring provider has a financial interest/ownership in the facility or
organization. This statute also extends to facilities and/or organizations
that the referring provider’s immediate family has a financial interest
in and/or holds ownership (Safian, 2009). Although the Stark Law only
regulates referrals for patients who have Medicaid and Medicare, most
states also have a version of this law. Penalties for violating the Stark
Law may include lifetime exclusion from participating as a Medicare
provider, repayment of all Medicare payments received for any referrals
that violated the law, and fines.
• Anti-Kickback Law is related to the Stark Law and prohibits a physician
from receiving payments in exchange for referring patients to other
facilities/organizations. Penalties for violating the anti-kickback law
includes fines that are three times the amount of renumeration plus
up to $50,000 per instance of kickback. Other penalties may include
incarceration and/or exclusion from participating in federal health care
programs (Office of Inspector General, U.S. Department of Health &
Human Services, 2019).

3.10 IMPLICATIONS FOR COMPLIANCE


In chapter one, the importance of a compliance program was discussed. This
chapter expanded on those principles by explaining how compliance with healthcare,
and specifically reimbursement practices, are regulated. Multiple agencies are
tasked with providing oversight to ensure individuals and organizations comply
with the rules and regulations that are in place. As a member of a health care
team, all members must practice in a legal and ethical manner and submit to all
compliance programs. When members fail to comply, there must be repercussions.
The compliance plan, along with the compliance policies and procedures manual,
must outline the penalties that will be levied for infractions.
Once a violation has been identified, the first step in the disciplinary action
plan includes notifying the individual(s) involved (Safian, 2009). Components of
the notification should include:

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1. The policy or law that the individual(s) is accused of violating. The notice
should be specific enough to allow the accused to understand what they
are alleged of violating and keep the focus on only this topic.
2. The evidence and/or information which led to the allegations against the
individual. Names of any witnesses or sources should not be shared with
the individual to avoid any conflict or prevent harassment.
3. How the investigation will be carried out, what level of disciplinary action
may be taken, and who will be involved in the investigative process.
4. Information regarding the individual’s right to defend his or her actions,
and the right to appeal any disciplinary actions imposed (Safian, 2009).

The level of disciplinary action that should be taken depends on the seriousness
of the infraction. Other concerns that should also be considered are whether the
accused has a history of prior violations, if they received appropriate training prior
to the infraction, and whether the violation was committed intentionally or if it was
a mistake. The disciplinary action plan should be progressive and implemented
consistently across the organization. The levels of disciplinary action include:

1. Verbal Warning: this level of disciplinary action is reserved for minor


infractions such as tardiness. The supervisor usually provides a verbal
warning and includes suggested corrective actions that should be taken.
The incident should be documented simply by including the time and
date of the warning, suggested corrective actions, and the accused
individual’s response (Safian, 2009).
2. Written Warning: when providing a formal corrective action, the
supervisor should use an official disciplinary action form to document the
encounter and corrective actions taken (Betterteam, 2019). If additional
training is required, the deadline for completing the training should
be included in the action plan (Safian, 2009). The accused individual
should read the form, provide his or her signature and date, and receive
a copy of the signed form.
3. Formal Disciplinary Meeting: this level is reserved for violations that are
serious enough to require punitive action such as suspension (with or
without pay), demotion, and/or exclusion from a company benefit such
as an annual bonus (Safian, 2009). The meeting should be documented
using an official disciplinary action form, signed by the supervisor and
accused, and a copy given to the individual.
4. Termination: this level is the highest with the most severe consequence
and is reserved for serious infractions including major violations, or
for individuals who continue to violate policy despite being warned
repeatedly (Safian, 2009). Due to the seriousness of the violation and

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disciplinary action, the supervisor must provide thorough documentation


of all elements previously mentioned, along with copies of previous
warnings or notifications given to the individual, and all other records
that influenced the decision to terminate.

3.11 SUMMARY
Historically, insurance plans have not been available or affordable for many
Americans. As the types of plans available have evolved, so too has the focus from a
fee-for-service to a quality (outcome) metric. Americans now have more options for
insurance plans than ever before, yet still struggle with affordability. In an effort to
provide affordable options, new innovative insurance plans are being developed.
As a consumer, it is vital to remain current on such changes to make educated
decisions regarding your insurance coverage.
In order to protect citizens from fraud, abuse, and/or loss of personal health
information, governmental organizations provide oversite and governance of the
insurance industry. Health compliance programs are one way employers ensure
they remain current with policies and legislation regarding insurance regulations.
Failure to comply with compliance programs may result in disciplinary actions
up to and including termination. Therefore, it is crucial that all members of the
health care team are aware of the regulations and laws and adhere to policies
and procedures. Ignorance of the law is not a defense and may result in punitive
measures from the employer, as well as the governing organization.

3.12 DISCUSSION QUESTIONS


1. Discuss two examples of innovative insurance plans and how they
attempt to contain health care costs.
2. Compare and contrast the types of insurance.
3. Find a recent case in the media regarding a HIPPA violation. Discuss
issues regarding the case including what action violated HIPPA, what
punishment was imposed, and what was the maximum penalty that
could be imposed.
4. Describe the various penalties that may be imposed for noncompliance
with reimbursement practices.

3.13 KEY TERM DEFINITIONS


1. Accountable Care Organizations (ACOs) – a healthcare organization
that ties provider reimbursement to quality metrics and reductions in
the cost of care.
2. Electronic Health Record (EHR) – an electronic version of a patient’s

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medical history; may include all of the key administrative clinical data
relevant to the patient’s care including demographics, progress notes,
problems, medications, vital signs, past medical history, immunizations,
and laboratory and radiologic reports.
3. Federal Poverty Level (FPL) – a measure of income used by the U.S.
government to determine who is eligible for subsidies, programs, and
benefits.
4. Fee-for-service (FFS) – a payment model where services are unbundled
and paid for separately; payment is dependent on the quantity of care
rather than quality of care.
5. Health Maintenance Organization (HMO) – one type of insurance plan
that includes a set of network providers, hospitals, and other healthcare
providers who have agreed to accept payment at a certain level for any
services they provide.
6. Preferred Provider Organizations (PPO) – a type of insurance plan
that provides maximum benefits if members use an in-network provider,
but still provides some coverage for out-of-network providers.
7. Primary Care Physician (PCP) – sometimes referred to as a primary care
provider, a PCP is a healthcare professional who is chosen by or assigned
to a patient, provides primary health care, and acts as a gatekeeper to
control access to other medical providers and/or services.

3.14 REFERENCES:
Agency for Healthcare Research and Quality, AHRQ. (2011, October). Ensuring that
Patient-Centered Medical Homes effectively serve patient with complex health needs.
Patient-Centered Medical Home Decisionmaker Brief.
Altman, D., Cutler, D., & Zeckhauser, R. (2000) Enrollee mix, treatment intensity, and
cost in competing indemnity and HMO plans. National Bureau of Economic Research
Working Paper 7832. Journal of Health Economics, 22(1), 23-45.
American College of Emergency Physicians. (2019) EMTALA Fact Sheet. Retrieved
from https://www.acep.org/life-as-a-physician/ethics--legal/emtala/emtala-
fact-sheet/#:~:targetText=The%20Emergency%20Medical%20Treatment%20
and,has%20remained%20an%20unfunded%20mandate
Betterteam. (2019, July 29). Disciplinary Action. Retrieved from https://www.
betterteam.com/disciplinary-action
Center on Budget and Policy Priorities. (2019). Chart Book: Accomplishments of
Affordable Care Act. Washington, DC.: Center on Budget and Policy Priorities.
Centers for Medicare & Medicaid Services, CMS. (2019). Accountable Care Organizations
(ACOs). Retrieved from CMS.gov
Centers for Medicare & Medicaid Services, CMS. (2019). Code Sets Overview.

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

Retrieved from https://www.cms.gov/Regulations-and-Guidance/Administrative-


Simplification/Code-Sets/index.html
Centers for Medicare & Medicaid Services, CMS. (2015). Laws against health care
fraud resource guide. Retrieved from https://www.cms.gov/Medicare-Medicaid-
Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/fwa-
laws-resourceguide.pdf
Centers for Medicare & Medicaid Services, CMS. (2019). Medicaid eligibility. Retrieved
from https://www.medicaid.gov/medicaid/eligibility/index.html
Chernew, M.E., Mechanic, R.E., Landon, B.E., & Safran, D.G. (2011). Private-payer
innovation in Massachusetts: The ‘Alternative Quality Contract’. Health Affairs,
30(1), 51-61. DOI: 10.1377/hlthaff.2010.0980
Cystic Fibrosis Foundation. (n.d.) The Insurance Basics retrieved from https://www.cff.
org/Assistance-Services/How-Compass-Helps-People-With-CF-and-Their-Families/
Understanding-Insurance/Your-Insurance-Plan/The-Insurance-Basics/
Claxton, G., Rae, M., Long, M., Panchal, N., & Damico, A. (2015) Kaiser Family
Foundation Employer Health Benefits: 2015 Annual Survey. Menlo Park, CA.: Henry
J. Kaiser Family Foundation
Department of Human Services. (2017). Medical Assistance for children with disabilities
– TEFRA option. Retrieved from https://mn.gov/dhs/people-we-serve/people-with-
disabilities/health-care/health-care-programs/programs-and-services/ma-tefra.jsp
Department of Justice, DOJ. (2011). The False Claims Act: A Primer. Retrieved from
https://www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-FRAUDS_
FCA_Primer.pdf
Employee Disciplinary Action Form. (n.d.). Retrieved from https://www.centenary.edu
Garfield, R., Orgera, K., Kaiser Family Foundation, & Damico, A. (2019). The uninsured
and the ACA: A Primer – Key facts about health insurance and the uninsured
amidst changes to the Affordable Care Act. Menlo Park, CA.: Henry J. Kaiser Family
Foundation.
Glied, S.A., Ma, S., Borja, A. (2017). Effects of the Affordable Care Act on health care
access. The Commonwealth Fund retrieved from https://www.commonwealthfund.
org/publications/issue-briefs/2017/may/effect-affordable-care-act-health-care-
access
Heathfield, S.M. (2019). Health Insurance Portability and Accountability Act. The
balance careers: Human Resources, Compensation. Retrieved from https://www.
thebalancecareers.com/health-insurance-portability-and-accountability-act-1918152
HHS.gov. (2017). Health Information Privacy: Covered entities & business associates.
Retrieved from https://www.hhs.gov/hipaa/for-professionals/covered-entities/
index.html
HIPAA Journal. (2018). What is a HIPAA violation? Retrieved https://www.hipaajournal.
com/what-is-a-hipaa-violation/#:~:targetText=What%20are%20the%20

Page | 52
OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

Penalties%20for,per%20violation%20category%2C%20per%20year
Kaiser Family Foundation. (2019). Where are states today? Medicaid and CHIP
eligibility levels for children, pregnant women, and adults. Kaiser Family
Foundation. Retrieved from https://www.kff.org/medicaid/fact-sheet/where-are-
states-today-medicaid-and-chip/
Klees, B.S., Wolfe, C.J., & Curtis, C.A. (2009). Medicare & Medicaid: Title XVIII and
Title XIX of the Social Security Act. Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
Kongstvedt, P. (2020). Health insurance and managed care: What they are and how
they work (5th Ed). Burlington, MA: Jones & Bartlett Learning, LLC.
Lipson D, Rich E, Libersky J, Parchman M. (2011, October). Ensuring That
Patient-Centered Medical Homes Effectively Serve Patients With Complex
Health Needs. (Prepared by Mathematica Policy Research under Contract No.
HHSA290200900019I TO 2.) AHRQ Publication No. 11-. Rockville, MD: Agency for
Healthcare Research and Quality.
Medical Mutual of Ohio. (2019). HMO vs. PPO insurance plan. Retrieved from https://
www.medmutual.com/For-Individuals-and-Families/Health-Insurance-Education/
Compare-Health-Insurance-Plans/HMO-vs-PPO-Insurance.aspx
National Committee for Quality Assurance, NCQA. (2019). PCMH benefits to practices,
clinicians and patients. Retrieved from https://www.ncqa.org/programs/health-
care-providers-practices/patient-centered-medical-home-pcmh/benefits-support/
benefits/
Office for Civil Rights. (2019). U.S. Department of Health & Human Services. Health
Information Privacy: Your rights under HIPAA. Retrieved from https://www.hhs.
gov/hipaa/for-individuals/guidance-materials-for-consumers/index.html
Office of Inspector General, U.S. Department of Health & Human Services. (2019). A
roadmap for new physicians: Fraud & abuse laws. Retrieved from https://oig.hhs.
gov/compliance/physician-education/01laws.asp
Quora. (2018). What is HIPAA compliance? Retrieved from https://www.quora.com/
What-is-HIPAA-Compliance-1
Safian, S.C. (2009). Essentials of Health Care Compliance. Clifton Park, NY: Delmar,
Cengage Learning.
Social Security Administration. (2019). Medicare premiums: Rules for higher-income
beneficiaries. Retrieved from https://www.ssa.gov/pubs/EN-05-10536.pdf
Sunshine, P. (2016, June). How does an HMO plan work? 3 Tips for switching to an HMO
plan. Health Insurance. Retrieved October 24, 2019 from https://insights.ibx.com/
how-does-an-hmo-plan-work-3-tips-for-switching-from-a-ppo-to-an-hmo-plan/
U.S. Department of Health and Human Services, Office of Inspector General. (2019).
Health Care Fraud and Abuse Control Program Report. Retrieved from https://oig.
hhs.gov/reports-and-publications/hcfac/index.asp

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OVERVIEW OF HEALTHCARE COMPLIANCE HEALTH INSUR ANCE & REIMBURSEMENT

U.S. Department of Labor, USDOL. (n.d.). Health Plans & Benefits: Continuation of
Health Coverage – COBRA. Retrieved from https://www.dol.gov/general/topic/
health-plans/cobra
U.S. Department of Labor, USDOL. (n.d.). Health Plans & Benefits: ERISA. Retrieved
from https://www.dol.gov/general/topic/health-plans/erisa
Wolf, L. (2019). What does ERISA cover? The balance careers: Women in business,
Basics. Retrieved from https://www.thebalancecareers.com/what-is-erisa-
law-3515060

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4
4.1 LEARNING OBJECTIVES
Quality Improvement

1. Identify the essential components that organizations need for quality


improvement and patient safety.
2. Discuss the future of tailored therapeutics.
3. Analyze the issues surrounding producers of medical products.

4.2 INTRODUCTION
Quality improvement and patient safety in healthcare are the most important
aspects when caring for patients. This chapter will focus on the fundamentals of
patient safety and quality improvement for healthcare professionals to improve the
health of patients, families, and communities while lowering costs. This chapter
will also provide knowledge of various topics related to quality improvement as it
relates to healthcare compliance.

4.3 KEY TERMS


• Quality Improvement
• Risk Management
• Evidence-based practice
• Patient-centered care
• Workflow Design

The Institute of Medicine defines quality of care as the degree to which health
services for individuals and populations increase the likelihood of desired health
outcomes and are consistent with current professional knowledge (Institute of
Medicine, 2001). Quality improvements in healthcare are vital to improve patient
safety while reducing costs. In 2001, the Institute of Medicine’s Crossing the

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Quality Chasm: A New Health System for the 21st Century provided a guide for
changes that must take place in U.S. hospitals and healthcare organizations to
ensure the delivery of quality of care. The alarming statistic that approximately
98,000 hospital patients died in 1999 due to preventable medical errors highlighted
the need for this guide (Institute of Medicine, 2001). Also, a study out of Johns
Hopkins University states that medical errors are the third-leading cause of death
in the U.S. (Johns Hopkins Medicine, 2016).
The guide from this report listed six components of quality healthcare: safety,
effectiveness, efficiency, equity, timeliness, and patient-centeredness (Whedon,
2016). In order to move forward with discussing quality, we will first define these
components.
Patient safety is vital in healthcare. Safe and effective care is secure for
patients and utilizes cutting edge healthcare science to serve as the standard in
care delivery. Healthcare technologies are designed to improve patient safety and
streamline workflow while improving patient care quality (McGonigle & Mastrian,
2018). Healthcare providers must evaluate errors carefully and change processes
and protocols so that future errors do not occur. Due to the rapid changes in
technology, error reporting should prompt continuous quality improvements
within the healthcare system.

EFFECTIVE

EQUITABLE EFFICIENT

QUALITY

PATIENT-
SAFE
CENTERED

TIMELY

Figure 4.1: Components of Quality Healthcare


Source: Original Work
Attribution: Corey Parson
License: CC BY-SA 4.0

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Think About This Scenario

A patient arrives at the emergency room department complaining of difficulty


breathing. The doctor comes into the room to examine the patient and orders
IV heparin (a blood thinner) because the doctor believes the patient may have a
pulmonary embolism. The nurse administers the heparin on a misprogrammed
IV pump, causing the patient to hemorrhage and die. The pump is designed to
alarm using the dose checking technology; however, the nurse decided to bypass
this feature.
Here is another scenario: A nurse is administering medication to a patient
and goes to the OMNICELL (medication dispensing equipment) to gather
the medication. The system alerts the nurse that she is getting the incorrect
medication; however, the nurse bypasses the alerts several times and continues
to retrieve the medication assuming that the pharmacy had placed it in the
wrong location when the OMNICELL was filled. The nurse failed to realize she
was looking at what she thought was a generic name for the medication, when
she was actually pulling an entirely different medication and the system was
attempting to stop the nurse from making a huge mistake. The nurse moved
forward with administering the incorrect medication to the patient, and the
patient dies.  

Technology and electronic equipment can be great for healthcare, but if not
used properly they can cause great harm to the patient. Healthcare professionals,
therefore, must always keep the safety of the patient as a top priority when
using various medical technology. Busy healthcare professionals rely heavily on
equipment with the assumption that doing so will improve outcomes for the patient.
Healthcare professionals must always be alert and triple check, though, before
administering medications or performing any tasks that can potentially cause the
patient harm. Technology is not always the answer with regards to patient safety.
In order to be efficient, the care should also be cost effective without much
waste. Many hospitals are using the lean management system in order to reduce
costs while caring for patients. Between 2001 and 2003, hospital infection rates
alone accounted for over 9,000 deaths and $2.6 billion in excess costs (Hoeft &
Pryor, 2016). This issue prompted standardizing nursing processes to improve
direct patient care, communication, and medication administration (Boettcher,
Hunter, McGonagle, 2019). Workflow designs are important to help facilitate
patient care quality while reducing wastes and costs. If a healthcare provider has
to go out of the patient’s room every time they need to document vital information
into the chart, then the patient is placed at risk without their having the most up
to date information documented. For example, if a patient is on pain medication
directly after surgery while in the hospital, and the nurse comes into the patient’s
room to administer the medication but is distracted by doing other things for the
patient and then leaves the room failing to document the “as needed” medication

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into the chart, this oversight places the patient at risk for being given a duplicate
dose by another nurse. Having computer stations in every hospital room helps to
eliminate this problem and allows the nurse the opportunity to document vital
information in a timely manner while also reducing costs, eliminating waste, and
reducing potential harm to the patient.    

4.4 PATIENT-CENTERED CARE


The adoption of patient and family centered care is increasing within healthcare
organizations across the U.S. to facilitate engagement of patients and families as
partners in their care (DeRosa, Nelso, Delgado, 2019). In the past, healthcare was
driven by the fee-for-service model. The insurance and federal payers reimbursed
the providers and healthcare facilities based on the service that was provided.
Currently, payment models are moving away from the fee-for-service model and
are moving instead toward reimbursements for prevention and value-based care,
also termed pay for performance. New quality models for payments are emerging
to include the Patient Centered Medical Home model and Accountable Care
Organizations (Accountable Care Organization, 2015). Providers are held as being
accountable for the quality of care the patient receives.
Due to the different interpretations of what quality means, standardized
measurements were developed and established to offer healthcare providers a
guide to use; they are listed as Healthcare Effectiveness Data and Information Set
(HEDIS measures). These measurements are also used for more than 90% of the
health plans in the U.S. (Whedon, 2016). HEDIS provide a set of standardized
performance measures for healthcare performance-reporting to hold organizations
accountable for achieving results. The focus is on prevention and screening, access
to and satisfaction with various health care services, and measures that are used
for specific procedures. The purpose of HEDIS measures is to prevent healthcare
quality’s failing to rise in proportion to rising healthcare costs. Therefore, HEDIS
can encourage accountability and quality in healthcare.

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Nurse

Surgeon Insurer

Patient

Doctor Utilization
Review

Dentist Doctor

Figure 4.2: Patient Centered Medical Home Model


Source: Original Work
Attribution: Corey Parson
License: CC BY-SA 4.0

Example

Here’s an example of this new quality payment model in this scenario: A 55


year old female patient with a diagnosis of hypertension and diabetes visits the
primary care physician for a routine yearly visit. The provider views the quality
metrics that are populating in the electronic medical record based upon this
patient’s age, gender, and diagnoses listed in the chart. The provider therefore
orders a mammogram, blood work, and a referral to podiatry. The provider is
now accountable for ensuring results return from the blood work, mammogram,
and a physician note from podiatry. The patient must now be notified for any
follow up visits or changes to medication if they are needed. This shows the
provider is using the HEDIS measures that are populated in all electronic
medical records and that reports can now be used based upon if the provider
“met” these quality measures.

The importance of patient-centered care focuses on not only the patient’s


diagnosis but also the patient’s health and well-being. Patient Centered Medical
Home models encourage the providers to improve quality of patient care. Not all
medical clinics have the status of “Patient Centered Medical Home,” but many are

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striving to move in this direction. Many clinics strive to attain a Patient Centered
Medical Home status. In order for a clinic to be recognized with this status, the
clinic must meet a minimum of six structural standards, including the following:
patient-centered access, team-based care, population health management,
care management, care coordination and transitions, and quality performance
and improvements. Population health management includes treating patients
with similar diagnoses using these quality guidelines to improve a community.
For example, many ambulatory clinics are integrated into a population health
management database where certain quality metrics are monitored over time
to view the outcomes of a large population of patients. One example of a quality
metric used in the population health management database is using diabetic
patients to answer such questions as the following: In a community, how many
diabetic patients are monitored and maintain a Hemoglobin A1c level below 7%?

4.5 CARE COORDINATION


Care coordination is vital to patient-centered medical care. Oftentimes, payers
such as insurance companies hire medical staff to call patients and make sure the
patients are taking their medication, the patients have the right medication, and
the patients are being followed by the primary care physician. Care coordination
helps to improve quality care as well as reduce the number of hospitalizations.
Transition of care is where medical staff offers additional support and often
sees the patient during the “in between time” after discharge from an inpatient
hospital stay and before the patient’s office visit with a primary care physician.
This supports the patient by ensuring they understand the medication regime and
by monitoring the patients for any adverse symptoms or problems before they see
their physician, all of which assists in reducing the amount of emergency room
visits and hospitalizations.  

4.6 EVIDENCE-BASED PRACTICE


Evidence-based practice is defined as the conscientious use of current best
evidence to make decisions about patient care (Melnyk, 2015). Healthcare
professionals are in the driver’s seat for improving healthcare quality while reducing
costs. It takes the employees who actually perform the daily tasks of caring for
patients to be able to see the results and also to give suggestions for better ways in
providing care or performing certain tasks.

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Example

Imagine going into the hospital and having a procedure that required anesthesia
and a Foley catheter to be placed to capture urine for a short period of time. The
Foley catheter is a collection bag with a tube inserted into the patient’s bladder to
collect urine. After surgery, the nurse fails to empty the bag routinely, does not
offer assistance in hygiene, and hangs the bag above the level of the bladder. All of
these choices are extremely bad for the patient and provide a breeding ground for
infection. Now, antibiotics must be initiated to help cure the patient’s infection,
and the catheter must be removed. Evidence-based practice has shown best
practices for staff when caring for patients with Foley catheters. New evidence
indicates to eliminate all use of Foley catheters in healthcare settings if at all
possible. New medical product inventions are becoming available for healthcare
workers to use in place of Foley catheters. This development occurred because
of evidence-based practice in healthcare, which is used to guide clinical practice
interventions, and due to the efforts of curious and inquisitive clinicians who
are constantly working to improve patient care. Healthcare workers can have
a positive impact on future changes of processes, protocols, and technology to
improve the quality of patient care.

4.7 QUALITY CONTROL & WORKFLOW DESIGN

Figure 4.3: Healthcare Workflow Design


Source: 123rf.com
Attribution: User “elenabsl”
License: elenabsl © 123rf.com. Used with permission.

Workflow design is where healthcare professionals can map out processes


within a healthcare organization to identify where improvements or changes need
to be made (McBride & Tietze, 2019). The goal of workflow design is to improve
the quality of patient care, reduce patient wait times, and improve patient safety.  

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Think About This Scenario

A physician in an internal medicine office sends a patient’s prescription


electronically to the pharmacy. The medication was an antibiotic to help cure
an upper respiratory infection. The physician tells the patient that they can pick
up their prescription from their pharmacy after they leave the clinic. However,
after the physician enters the medication into the electronic e-prescribing
system and signs the order, the physician changes their mind and decides that
a different antibiotic would be better for the patient. The patient presents to
the pharmacy and picks up two different antibiotics to take. The pharmacist
did not call and question the order but instead filled both prescriptions for
the patient. The patient presents back to the physician’s office the next day
with severe abdominal discomfort. This is where workflow design and quality
of care can come together. How could have this situation been handled
differently? The physician could have simply asked the nurse to phone the
pharmacy to let them know of the changes that were made for the patient
prior to the patient leaving. Not doing this caused undue harm to the patient
and could have potentially caused severe harm had another medication been
prescribed. Workflow designs should be built into discussions when related to
compliance, quality, and patient safety.

4.8 DATA ANALYSIS AND ANALYTICS


Reviewing quality data is important to engage an organization in developing
policies and procedures using meaningful data and analytics to help support an
organization’s strategic plan. Many software programs align data that consists of
clinical and financial data to integrate the information, which can improve reporting,
analytics, and research (McBride & Tietze, 2019). Many healthcare organizations,
though, struggle to use data effectively to improve clinical operations, reduce costs,
and improve research. According to the National Quality Strategy (NQS, 2019),
data analysis and analytics have three areas to focus on: better care, healthy people
and communities, and affordable care. Data must be entered into systems correctly
for the data to be used meaningfully. Charts, bars, graphs, and flowsheets can be
used to showcase data that is essential for quality reporting purposes, payments,
research improvements in workflow designs, and enhancements to policies and
procedures.

4.9 QUALITY REPORTING


The success of the National Quality Strategy depends upon the ability of
providers and staff to successfully utilize data to improve quality metrics and
increase patient satisfaction scores (Sewell, 2019). Quality metrics in healthcare are
vital to improve patient care, foster a healthier community, and lower healthcare
costs. Measurement is the first step for improvement. Patient satisfaction surveys

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are one technique many healthcare organizations utilize to make improvements in


patient care. These surveys are often sent to the patient after a hospital stay, and
organizations will often call patients to complete a survey via phone as well. Around
2008, the Centers for Medicaid and Medicare set requirements for hospitals to
survey patients regarding their experiences from their stay (CMS.gov, 2012). A
tool, called the Health Consumer Assessment of Health Providers and Systems
(HCAPS), was developed as a standardized survey tool designed for discharged
patients’ experiences. The data collected from these surveys must be reported
to the Centers for Medicaid and Medicare, where they are tracked over time and
benchmarked to other hospitals. This data is also available for the public to view. If
hospitals choose to not participate in these surveys, then they will receive a financial
reduction in payment from federal payers for their patients’ hospital stays.
The quality of nursing care can influence a hospital’s performance in some of
the most core areas within the HCAHPS. For more specific data, some nurse leaders
in organizations choose to participate in a survey called the National Database of
Nursing Quality Indicators (NDNQI) (Sewell, 2019). This is a survey specific to
the nursing care a patient receives during their hospital stay. Hospitals usually
will submit nursing data to this national database; the data is then analyzed and
reports are given back to the hospital. Nurse leaders and nurse managers can then
synthesize the data related to their specific units to focus on the goal of improving
the quality of patient care. Some examples of this data include nurse to patient
ratios, falls, nursing turnovers, pressure ulcers, infections, restraint use, and
nosocomial infections (Press Ganey, 2018). For example, if a patient comes in to
stay at the hospital after a recent ortho surgery and then develops a pressure ulcer or
experiences a fall with injury, these costs are not covered by federal payers and will
often lead to longer patient stays in which the hospital will have to take ownership
of the costs related to these events. These events not only have a negative impact
on the hospital financially, but also influence their scores from the surveys, which
can cause them to experience a larger negative impact. It is therefore imperative
that hospitals have surveys and monitor their data and results to improve patient
care while lowering costs.

4.10 IMPLICATIONS FOR COMPLIANCE &


SUMMARY
How does quality affect compliance in healthcare? Many healthcare
organizations have compliance departments that view and monitor tasks, protocols,
and other activities to ensure patient care is not jeopardized when it comes to
quality care. Compliance is an important factor to monitor because it ensures that
tasks are being performed in a timely manner, results are reviewed efficiently, and
standards of practice are being followed. Oftentimes, risk management departments
must get involved with issues that concern patient safety, or situations that arise
and cause harm, even death, to patients. Risk management is a department in

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which a hospital employs several nurses and medical lawyer(s) whose roles are
to investigate events that impact patient safety, patient harm, and death related
events. Their roles are vital to the hospital and help improve quality, prevent
errors from occurring by setting appropriate policies and procedures in place, and
educate staff on the required protocols.

Think About This Scenario

A patient goes into the operating room to have a scheduled knee surgery. The
patient was going to have his right knee operated on and a knee replacement
performed. However, the surgeon operates on the left knee instead. The patient
did not consent for his left knee to be operated on. The consent was for the
right knee. Now the patient has endured a long surgery that he must heal from
on the wrong lower extremity. The risk management department gets involved
in case there is litigation that comes from this situation. Also, the compliance
department needs to be involved to audit what went wrong. Did the physician
fail to mark the wrong leg? Did the nurse fail to check behind the physician to
ensure the correct leg was being operated on? Was the “time-out” procedure
not followed? How do things like this example go wrong in health care? Sadly,
the patient had to go back into the operating room to have another surgery. The
hospital will have to endure the costs of the first surgery and hope for litigation
not to occur. Compliance gets involved to set standards of care and policies and
procedures so that scenarios like this example do not recur. Staff must be trained
on any new policies and procedures as well. Adherence to these new policies and
procedures must occur in an effort to prevent harm to patients.

Healthcare organizations must go through accreditation processes that


are designed to require the organization to self-evaluate and report, maintain
compliance regulations, and be transparent with information (Barata, Cunha,
Santos, 2018). The shift in payment models already discussed in this chapter also
has significant compliance implications. Quality patient care and value-based care
are now linked and tied to payments to providers and healthcare organizations,
as compared to previous payment models in which quality was not the focus.
Compliance departments should connect with various departments within the
clinical setting in an organization, especially on matters related to preventing
infections and ensuring patient safety. Oftentimes, healthcare organizations
operate in “silos” where staff and departments do not communicate with each other
and the complete big picture can often be missed. In previous years, healthcare
compliance departments were more focused on billing, physician agreements
with payer sources, and laws and regulations. Now, compliance should focus on
patient care and must extend to the clinical and quality areas within a healthcare
organization (Smith, Welker, & Zeko, 2019). Due to rapid changes in healthcare,
especially related to quality, payments can now be affected and penalties and

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incentives can be given. This topic will be discussed further in the technology
chapter. “Hospitals must bring the bedside and the business side together to
communicate and collaborate on compliance” to allow risks to be managed in a way
to improve the lives of patients and make a positive impact on the organization’s
financial growth (Smith, Welker, Zeko, 2019).  

4.11 DISCUSSION QUESTIONS:


1. What is the difference in the compliance department and the risk
management department in a healthcare setting? What are the roles and
functions of each? Explain.
2. What is the difference between fee-for-service and pay-for-performance?
Why are insurance payers and federal payers concerned with quality as it
relates to reimbursement?
3. Should providers continue to be paid by a healthcare organization if their
quality scores are poor? Why or why not?  
4. What are your thoughts on rating a provider based on quality care?
(Much like rating a restaurant or a hotel where it is visible and published
on the internet)
5. How can population health improve quality of care?

4.12 KEY TERM DEFINITIONS


1. Quality Improvement—a framework which is used to improve how care
is delivered to patients.
2. Risk Management—any activity, process, or policy to reduce liability for
a patient’s safety and financial wellbeing.
3. Evidence-based practice—the use of current best evidence in making
decisions about patient care.
4. Patient-centered care—providing care that is respectful and responsive
to individual patient preferences, needs, and values and ensure that
these choices guide all clinical decisions.
5. Workflow Design—the flow of work through time and space to encompass
all activities, technologies, and people to promote and provide quality
healthcare.

4.13 REFERENCES
Accountable Care Organization 2015 Program Analysis Quality Performance Standards
Narrative Measures Specifications. (2019, October 3). Retrieved from The Centers
for Medicare and Medicaid Services, 2015: www.cms.gov/Medicare/Medicare-Fee-
for-service-payment/sharedsavingsprogram/downloads/ACO-NarrativeMeasures-
Specs.pdf
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Ahmad, F., Norman, C., O’Campo, P. (2012). What is needed to implement a Computer-
Assisted Health Risk Assessment Tool? An Exploratory Concept Mapping Study.
BMC Med Inform, 12(1), pg. 149.
American Recovery & Reinvestment Act of 2009. Retrieved from: http://www.
govtractus/congress/billepd?bill=h111-1.
Barata, J., Cunha, P., & Santos, A. (2018). Mind the Gap: Assessing Alignment between
Hospital Quality and its Information Systems. Information Technology for
Development, 24 (2), pg. 315-332.
Berner, E. (2009). Clinical Decision Support Systems: State of the Art. Retrieved from:
http://healthit.ahrq.gov/sites/default/files/docs/page/pdf.
Boettcher, P., Hunter, R., & McGonagle, P. (2019). Using Lean Principles of Standard
Work to Improve Clinical Nursing Performance. Nursing Economics Volume 37
Number 3, 152-163.
Campbell, R. (2013). The Five Rights of Clinical Decision Support: CDS Tools Helpful for
Meeting Meaningful Use. Journal of AHIMA. 84(10), pg. 42-47.
CMS.gov. (2012). Stage 2 Overview tipsheet. Retrieved from https://www.cms.gov/
Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downlaods/
Stage2Overview_Tipsheet.pdf
DeRosa, A.,Nelson, B., Delgado, D. & Mages, K.; Journal of the Medical Library
Association, July2019; 107(3): p.314-322.
Greenes, R. (2014). Clinical decision support: The road to broad adoption (2nd ed.).
Philadelphia, PA: Elsevier.
Hoeft, S. &. (2016). The power of ideas to transform healthcare: Engaging staff by
building daily lean management systems. Boca Raton, FL: CRC Press, Taylor &
Francis Group.
Institute of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the
21st Century. Washington, D.C.: National Academies Press.
Joshi,M., Ranson, E., Nash, D. & Ranson, S.(2014). The healthcare quality book. Vision,
Strategy, and Tools (3rd ed). Chicago, IL: Health Administration Press Marketing
Kiron, D., Ferguson, R., & Prentice, P. (2013). From value to vision: Reimaging the
possible with data analytics: What makes companies that are great at analytics
different from everyone else. (Research Report). Cambridge, MA: MIT Sloan
Management Review. Retrieved from: http://www.sas.com/content/dam/SAS/
en_us/doc/whitepaper2/reimagining-possible-data-analytics-106272.pdf
Melnyk, B. &.-O. (2015). Evidence-based practice in nursing & healthcare. A guide to best
practice. In B. &.-O. Melnyk, Evidence-based practice in nursing & healthcare. A
guide to best practice (3rd ed.) (pp. 3-23). Philadelphia, PA: Wolters Kluwer.
McBride, S. & Tietze, M. (2019). Nursing informatics for the advanced practice
nurse (2nd ed). New York, NY: Springer Publishing Company (Accountable Care
Organization 2015 Program Analysis Quality Performance Standards Narrative
Measures Specifications, 2019)

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McGonigle, D. & Mastrian, K. (2018). Nursing Informatics and the foundation of


knowlede (4thed). Burlington, MA: Jones & Bartlett Learning
National Quality Stategy. Healthcare Research and Quality. (March 2017). Retrieved
from: https://www.ahrq.gov/workingforquality/about/index.html.
Press Ganey. (2018). Nursing quality (NDNQI). http://www.nursingqualtiy.org/About-
NDNQI
Sewell, J.(2019). Informatics and Nursing: Opportunities and Challenges. Philadelphia:
Wolters Kluwer.
Sheroff, J. (2012). Improving outcomes with CDS support: An implementer’s guide (2nd
ed.). Chicago, IL: HIMSS.
Smith, K., Welker, R., & Zeko, K. ( 2019). 5 Evolving Compliance Risks That Should Be
On Your Radar. Healthcare Financial Management. May2019, p20-26.
Souza, N., Sebaldt, R., Mackay, J.,Provok, J.,et.al. (2011). Computerized Clinical Decision
Support-Systems for Primary Preventative Care: A Decision Maker, 6(87).
Study suggests medical errors now third leading cause of death in the U.S. (2019, 10 1).
Retrieved from John Hopkins Medicine, 2016: http://www.hopkinsmedicine.org/
news/media/releases/study-suggests-medical-errors-now-third-leading-cause-of-
death-in-the-us
Telemedicine defined. (2019, 10 1). Retrieved from American Telemedicine Association:
http://www.americantelemed.org/i4a/pages/index.cfm?pageid=3333
Thede, L. & Sewell, J.(2010). Informatics and nursing (3rd ed). Philadelphia,
PA: Wolters Kluwer.
Whedon, J. M. (2016). Relevance of Quality Measurement to Integrative Healthcare in
the United States. The Journal of Alternative and Complementary Medicine Volume
22, Number 11, 853-858.

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5
5.1 LEARNING OBJECTIVES
Strategic Planning

1. Describe how leadership plays a part in strategic planning for an


organization.
2. Define the steps of developing a strategic plan.
3. Identify the components of developing the mission, vision, values, and
goals for a strategic plan.
4. Generalize ways in which to communicate a strategic plan.
5. Identify how strategic planning fits into health care compliance.

5.2 INTRODUCTION
Strategic planning is heavily rooted in healthcare compliance. Likewise,
leadership in health care organizations has a significant impact on strategic
planning processes. Strategic planning helps to move an organization toward
common goals and objectives, but the definition of strategic planning differs
among many healthcare organizations. This chapter will address the foundations
of a strategic plan; developing the mission, vision, values, and goals of the plan;
and communicating the strategic plan with key stakeholders. It will also explore
healthcare compliance as it relates to strategic planning in healthcare organizations.

5.3 KEY TERMS


• Strategic Plan
• Mission
• Vision
• Values
• Operational Risk

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• Regulatory Risk
• Financial Risk

5.4 LEADERSHIP AND STRATEGIC PLANNING


Leadership has a significant impact on the strategic planning of any workplace
(Jabbar & Hussein, 2017). The foundation of leadership is often described as
planning and vision. Developing a strategic plan helps leaders determine the
direction and goals for the workplace to achieve its outcomes. The strategic plan
also helps the leadership of any institution link the heart of the institution with its
body or purpose (Jabbar & Hussein, 2017). Imagine a workplace whose employees
did not believe in the leadership or product that the institution was developing
or delivering. How successful do you believe this product would actually be?
Would the leadership of this company ever truly be successful? Now, imagine a
company with a leadership that involved the employees in the planning and vision
of the product they were producing. How successful do you believe this product
would be? Leaders often give direction for an institution, but employee buy in and
involvement makes the institution overall more successful.
Its leadership is responsible for developing the strategic planning process
and moving the institution toward the goals it wishes to accomplish. In strategic
planning, leaders are often responsible for many different roles. These roles include
the following:

• Preparing the environment for change


• Creating a leadership team that involves key players in the institution
• Developing a vision and mission that clarifies the strategy for the entire
institution (Moesia, 2007)

Assuring these steps are followed will help the leadership of any institution establish
a well-defined strategic plan and gain employee support and understanding.

5.5 FOUNDATION OF A STRATEGIC PLAN


When developing a strategic plan, an institution most often refers to its
foundation. For example, if our company developed programs to educate healthcare
professionals in underserved areas, our foundation would be the population we
wanted to serve. How would we begin to lay the foundation for building a strategic
plan, to serve our population? What stakeholders would we need to involve in order
to identify all of our needs? What are our institutions’ goals? How will we define
success? All of these questions help us to identify our foundation for developing
our institutions’ strategic plan.

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Figure 5.1: Foundation for Developing a Strategic Plan


Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

Identifying stakeholders early in the strategic planning process helps


the institution align its mission, vision, strategy and goals. For example, key
stakeholders in our company who are developing programs to educate healthcare
professionals in underserved areas would involve institutions of higher education,
healthcare facilities and partners, community partners, technology partners, and
publishing partners. Involving these stakeholders in our institutions’ strategies
and goals will help us better define our success.
An example of a goal and strategy for our imaginary company that will develop
programs to educate healthcare professionals in underserved areas could look
something like this:

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Foster and promote positive


community outreach strategies to
promote student learning while
educating the community on
healthcare products

Company X will maintain


healthcare career program
Review and monitor viability and promote growth of Participate in
healthcare recruitment events for
the company by increasing
programs that use healthcare professions
diversity and reaching and community
company products.
under-represented groups events.
through community outreach.

Participate in community
events to increase
relationships with community
partners and industry.

Figure 5.2: An Example of a Goal and Strategy for Company X


Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

Here, the large middle circle represents the company’s goal, while the outside
circles represent the company’s strategies and actions for reaching this goal.

5.6 MISSION, VISION, VALUES, AND GOALS


Once an institution’s leadership has employee and stakeholder support, the
strategic plan development process can begin. This process begins by developing
the mission, vision, values and goals for the institution.

5.6.1 Mission and Values


An institution’s mission often relates to its overarching purpose and is typically
communicated with the entire institution, its stakeholders, and the public in
written form. A mission statement answers the questions of who the institution
is, what they do and value, and how they would like to move forward in the
future. A mission statement communicates the institution’s reason for being and
how it plans to serve its key stakeholders. Some mission statements also include
the institution’s values or beliefs. For example, the mission statement from the

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international coffee company Starbucks, updated in 2019, includes four guiding


principles that also communicate its values.

STARBUCKS MISSION AND VALUES

OUR MISSION
To inspire and nurture the human spirit – one person, one cup, and one
neighborhood at a time.
OUR VALUES
With our partners, our coffee, and our customers at our core, we live these
values:
• Creating a culture of warmth and belonging, where everyone is
welcome.
• Acting with courage, challenging the status quo, and finding new
ways to grow our company and each other.
• Being present, connecting with transparency, dignity, and respect.
• Delivering our very best in all we do, holding ourselves accountable
for results.
(Starbucks website)

The mission of any institution needs to focus on several key areas, including the
following:

• What service or commodity it wants to produce and work to improve?


• How to increase the wealth or quality of life of its stakeholders.
• How to provide opportunities for the productive employment of people.
• How the institution is creating high quality and meaningful work for its
employees.
• How does the institution live up to the obligation of creating fair and
equitable employee wages?
• How does the institution provide fair return on capital (O’Hallaron & O’
Hallaron, 2000).

The mission statement should be clear and be used to show where the company
wishes to go.

5.6.2 Vision
An institution’s vision differs from its mission in that the vision identifies the
future of the organization along with its aspirations. In many ways, you can say
that the mission statement lays out the organization’s purpose for being, and the

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vision statement then says, based on that purpose, this is what we want to become.
A vision statement helps to create the desired image of your future institution.
Do you want your company to be known for creating the next iPhone app? Is
your vision to be known for the best group communication text app? Your vision
statement will need to address your targeted environment and what you aspire to
accomplish.
Your vision statement for the institution also needs to include the “big picture”
of your company. For instance, your vision may be to provide an international
group communication app, but your vision statement would not include specific
strategies to get you to this goal. An example can be found in the Starbucks
Coffee’s corporate vision “to establish Starbucks as the premier purveyor of the
finest coffee in the world while maintaining our uncompromising principles while
we grow” (Starbucks website). Aiming to be the premier coffee provider means
that Starbucks Coffee wants to provide coffee of the best quality (Gregory, 2019).
According to Gregory, “the company achieves this component of its vision statement
by continuing its multinational expansion as one of the largest coffeehouses and
coffee companies in the world” (Gregory, 2019, p. 2).

5.6.3 Goals
The overall purpose of developing goals for your strategic plan is to establish
an achievable action plan for carrying out your mission and vision. Many strategic
plans have failed because they were too complex or ambitious (Pract, 2009). The
individual goals may not address all of your institution’s limitations, but they
should put you on a path of improvement. These goals can be readdressed yearly if
needed, as long as they relate back to your mission and vision.
Each goal should also have an action plan that describes what the company will
do in order to reach each outcome. For example, Starbucks included in its vision
several of its goals, including:

• Premier purveyance.
• Finest coffee in the world.
• Uncompromising principles.
• Growth.

Establishing goals can be put into practice as we begin to imagine a company that
will develop programs to educate health care professionals. We could establish
yearly goals or actions steps that will help us reach our company’s mission. Some
of this company’s goals may be as follows:

• Company X will maintain healthcare career program viability and


promote growth of the company while increasing diversity and reaching
under-represented groups through community outreach.

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• Company X will develop a high standard of excellence in teaching and


learning by engaging faculty with education, training, and mentoring
opportunities needed to meet the goals of the health care program.
• Company X will promote a student-centered focus that will foster
success, learning and improved program completion rates for all
healthcare program students.

5.7 COMMUNICATING THE STRATEGIC PLAN


Your company’s strategic plan will serve no purpose without communication.
As you can see from the many steps listed above, the development of a strategic
plan involves much time and effort. You will waste your time and effort unless you
communicate this plan with the stakeholders and people upon whom it will have
an impact. Communication of your strategic plan should involve communicating
upward, downward, across, and outward (Hambrick & Cannella, 1989). Upward
communication involves persuading upper management of the internal mission
and vision within the strategic plan. Communicating downward means enlisting the
support of the employees within a company who will be carrying out the strategic
plan. Communicating across and outward involves other areas within the company
and stakeholders that will be affected by the strategic plan. For instance, in our
company, we will need financial support from across our company to develop and
implement our products, and communication outside our company for community
and student involvement.
Many institutions and companies communicate their strategic plan in a one-
page format called a “snapshot.” This allows the strategic plan to be shared with
all parties in a simple manner. An example from our healthcare company could be
as follows:

20XX – 20XX

Company X Strategic Plan Snapshot

Mission Statement:
As an academic healthcare educator, the mission of Company X is to educate the
next generation of healthcare professionals in a collaborative and inclusive inter-
professional learning environment, while providing accessible and culturally
competent healthcare and wellness education through evidence-based practice.
Through innovative education, interdisciplinary care, and community-based
practice initiatives, the company is committed to leading the way in improving
community health and reducing health disparities.

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Long Term College Goals 20XX - 20XX


1. Company X will establish and implement well-defined and published
policies and procedures that utilize best practice in order to improve
overall company operations.
2. Company X will develop a high standard of excellence in teaching and
learning by engaging faculty with educational, training, and mentoring
opportunities needed to meet the goals of the company.
3. Company X will promote a student-centered focus that will foster
success, learning, and improved program completion rates of all
healthcare program students while implementing exceptional advising
strategies.
4. Company X will maintain healthcare career program viability and
promote healthcare program growth while increasing diversity and
reaching under-represented groups through community outreach.

5.8 STRATEGIC PLANNING IN HEALTH CARE


Strategic planning in healthcare is really no different than in the institutions
we have discussed earlier in this chapter. Strategic planning in health care involves
outlining the action steps to meet your organization’s goals (Regis College, 2017).
Many of today’s health care models require a more patient-centered and value-
based approach to health care (Regis College, 2017). Norris (2016) claims that
“strategic planning helps a healthcare organization do a better job of focusing its
resources and energy” (p. 1). This process can also help to identify strengths and
weaknesses within a health care organization and, ultimately, to minimize those
issues.
Perera & Peiro (2012) describe five indicators that, in combination, suggest
that all healthcare organizations need a strategic plan. These indicators include
the following:

1. Informed, demanding, and non-loyal patients and clients who have a


right to choose their healthcare organization.
2. Increasingly skilled and professional competitors (facilities and
physicians).
3. Due to economic crisis in certain areas, there are limited resources for
production.
4. The overall focus has shifted from the product or service delivered to the
patient’s experience.
5. The increase in population has led to an increase in the size and
complexity of the healthcare organization. (Perera & Peiro, 2012).

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These changes in our health care environment are often the driving force for an
organization’s strategic plan. The strategic plan not only moves the organization
forward but also helps the organization remain in the forefront of constant changes
and challenges in the health care market. As Johnson asserts, “To be successful
in the future, no matter how turbulent the path forward may be, organizations
need to create a vision based on the best future assumptions they can identify”
(Johnson, 2017, p. 1).

5.9 IMPLICATIONS FOR COMPLIANCE


Health care related laws and regulations remain a challenge for many healthcare
organizations. Many hospitals and healthcare organizations have begun looking
at healthcare compliance through a different lens. According to Cerrato, “Instead
of looking at them as routine operational responsibilities, they are incorporating
compliance into a carefully crafted strategic plan, one that not only reduces the
risk of large penalties but may even provide revenue opportunities” (Cerrato, 2013,
p. 1).
The healthcare organizations of today are faced with many different risks that
can potentially keep them from reaching their goals as set forth in the organization’s
strategic plan. These include market changes, workforce changes, technology
changes and aging population changes (see graph below).

k
t e g i c Ris Oper
ation
Stra ning) al Ris
(plan k
Inability to achieve
Organizational Strategic Plan
Regu
lato
(com ry Risk cial Risk
plian
ce) Finan

Figure 5.3: Potential Risks Preventing a Company from Achieving Strategic Plan Goals
Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

Many healthcare organizations include compliance in the framework of


their strategic plan. For instance, the strategic plan from Tuscola Behavioral
Health Systems fiscal year 2017-2019 identified compliance as one of their “core
strategies” for operation. Tuscola Behavioral Health Systems stated, “we will
maintain a health care compliance system that will serve as a guideline for its good

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faith efforts toward compliance with state and federal regulations that apply to its
services” (p. 9). Their strategic plan addressed compliance through the long-range
initiative, goals, and objectives/challenges identified in the chart below.

# Long- Range Goals Objective/Challenges


Initiative
Provide quality • Achieve and 1. Achieve goals as defined by
services within maintain full MDHHS, MSHN and other
the guidelines compliance regulatory entities (QAPIP,
established by to standards/ BH-TEDS, MMPBIS, MSSV,
regulatory and require- KPIs, etc.).
accrediting ments from 2. Achieve effective
organizations. all governing, administration of the annual
D. Compliance

regulatory, and Compliance Plan.


legal entities
(including 3. Ensure required and valid
MDHHS, MSHN data elements are gathered
and CARF) via the EHR for reporting
purposes.
• Ensure effective
and secure use 4. Ensure effective and secure
of the Electronic use of the EHR.
Health Record 5. Complete the provider
(EHR) network monitoring to ensure
compliance with contract and
regulatory standards.
Table 5.1
Source: Tuscola Behavioral Health Systems
Attribution: Tuscola Behavioral Health Systems
License: © Tuscola Behavioral Health Systems. Used with Permission.

In many ways strategic planning and compliance seem to fit together in the health
care environment. In this ever-changing and competitive environment, healthcare
organizations are going to continue to find themselves amongst change and
evolution. An organization’s strategic plan and its compliance with established
mission and values will help it venture through the waves of change and future
growth.

5.10 SUMMARY
Strategic planning is often found at the core of many institutions and
organizations. The leadership of an organization gives the direction and foundation
for strategic planning from within the organization. Involving the employees of
an organization in the strategic planning process helps to assure employee buy-in
and helps to move the organization toward common goals and objectives that will
make an impact on the company’s outcomes. The strategic plan’s mission, vision,
values, and goals must be communicated throughout the company and with its

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stakeholders in order to be successful. Involving compliance with an institution’s


strategic plan will help the institution maintain healthcare compliance and will
serve the institution’s venture through the waves of future change and growth.

5.11 DISCUSSION QUESTIONS


1. How does an institution’s leadership play a part in the development and
implementation of a strategic plan?
2. Why is it important to involve stakeholders in the development process
of your strategic plan?
3. Identify and define the important components of a strategic plan.
4. If you were in charge of developing a strategic plan for a company that
created programs to educate healthcare professionals in underserved
areas, with whom would you communicate the strategic plan and how
would you communicate your plan?
5. Describe how an organization can include compliance in their
strategic plan?

5.12 KEY TERM DEFINITIONS


1. Strategic Plan – a document that describes the direction of a company
or institution.
2. Mission – a formal summary of the aims and values of a company,
organization, or individual.
3. Vision – a description of what an organization would like to accomplish
in the future.
4. Values – a statement that describes the top priorities of a company or
organization and what its core beliefs are.
5. Operational Risk – the risk of a change in value caused by company
losses that were not expected.
6. Regulatory Risk – the risk of a change in laws or regulations that
may affect company operations.
7. Financial Risk – the risk that a company or institution may not be
able to meet its financial obligation.

5.13 REFERENCES
Carriere, B., Muise, M., Cimmings, G., & Newburn-Cook, C., (2009). Healthcare
succession planning: An integrative approach. The Journal of Nursing
Administration. 39(12). pg. 548-555.

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Cerrato, P., (2013). Compliance needs a shred strategic plan. Healthcare Finance.
Retrieved from: https://www.healthcarefinancenews.com/news/compliance-needs-
shrewd-strategic-plan
Gregory, L. (2019). Starbucks Coffee’s Mission Statement & Vision Statement (An
Analysis). Panmore Institute. http://panmore.com/starbucks-coffee-vision-
statement-mission-statement
Hambrick, D. & Cannella, A. (1989). Strategy implementation as substance and selling.
The Academy of Management Executive. 3(4). pg. 278-285
Jabbar, A. & Hussein, A. (2017). The role of leadership in strategic management.
International Journal of Research – Granthaalayah, 5(5). pg. 99-106
Johnson, T. (2017). Strategic planning in the healthcare industry. Balanced Scorecard
Institute, retrieved from: https://www.balancedscorecard.org/BSC-Basics/Blog/
ArtMID/2701/ArticleID/1119/Strategic-Planning-in-the-Healthcare-Industry
Mosia, M.S. (2007). The importance of different leadership roles in the strategic
management process. S.A. Journal of HRM, 2(1). p. 26-36
Norris, T. (2016). Why is strategic planning so important? Healthcare Management
Consultants. Retrieved from: https://www.healthcaremgmt.com/why-is-strategic-
planning-so-important/
O’Hallaron, R., & O’ Hallaron, D., (2000). The Mission Primer: Four Steps to an Effective
Mission Statement. Richmond, VA: Mission Incorporated
Perera, P., & Peiro, M., (2012). Strategic planning in healthcare organizations.
Cardololgia, 5(8). 749-754.
Pract, J., (2009). Strategic planning: Why it makes a difference. Journal of Oncology
Practice. 5(3). Pg. 139-143.
Regis College., (2017). Understanding Strategic Planning in Health Care Organizations.
Retrieved from: https://online.regiscollege.edu/blog/understanding-strategic-
planning-health-care-organizations/
Starbucks Coffee Company. https://www.starbucks.com/about-us/company-information
Tuscola Behavioral Health System. Strategic Plan, FY 17-18. Retrieved from: https://
www.tbhsonline.com/images/pdf/Strategic-Plan-2018.pdf

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6
6.1 LEARNING OBJECTIVES
Managing Healthcare
Professionals & Strategic
Management of Human
Resources

1. Examine the management of different types of healthcare professionals


in the workforce
2. Describe ways to manage conflict in the work setting
3. Identify ways to retain employees in the work setting
4. Define and describe the different components of human resource
management in the workforce
5. Incorporate human resource strategies into the healthcare workforce

6.2 INTRODUCTION
Human resources management is a blanket term used to describe the
development and management of employees in the workplace. The term human
resources can be used to describe the department responsible for managing the
resources of a company as it relates to the employees, or to describe the employees
who work for an organization. Likewise, in healthcare compliance, human resource
management includes the development and administration of programs that are
designed to improve the productivity of an organization. This chapter will examine
the management of different healthcare professionals in the workplace, conflict in
the workplace, and employee retention. Incorporating human resource strategies
into the healthcare workforce as it relates to healthcare compliance will also be
explored.

6.3 KEY TERMS


• Management
• Human Resources
• Healthcare Workforce

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• Conflict
• Employee Retention
• Employee Laws
• Employee Regulations

6.4 UNDERSTANDING THE MANAGEMENT


OF HEALTHCARE PROFESSIONALS IN THE
WORKFORCE
As healthcare systems throughout the U.S. and nation have expanded,
increased attention is being placed on human resources management in the
healthcare workforce. Human resources, as pertaining to healthcare, can be
described as the management of the clinical and non-clinical staff responsible
for providing particular health intervention (World Health Organization, 2000).
The size, distribution, and composition within a county’s healthcare workforce is
often a concern (Kabene, Orchard, Howard, Soriana & Leduc, 2006). For example,
the number of available healthcare workers in a region often defines the facility’s
abilities to provide health care. Many times in today’s society, economic factors
play a large part in the health care of a region or county.
The healthcare workforce is also an important factor to manage in human
resources. Human resource personnel must consider the skill and training levels of
employees entering the work force. They can do so by thinking about the hospital
setting. For example, it would not be wise for an intensive care unit to hire all new
graduate nursing staff who had no experience in taking care of patients in intensive
care. Continued education and in-service training are often required to enhance
classroom skills adequately for a real-world setting. A properly trained workforce
is important for any healthcare setting.
In today’s ever-changing economy, many organizations have implemented
various health resource initiatives in an attempt to increase efficiency (Kabene,
et. al, 2006). Outsourcing labor or hiring contract labor is often necessary to meet
the needs of the healthcare facility and the region in which it serves. This strategy
helps the healthcare facility ensure that it can meet the needs of its patients and
work force. Other health care initiatives include attempts to increase equity and
fairness as well as improving patient satisfaction with the care provided.
Human resource professionals face many different obstacles as they work to
deliver high quality health care to their patrons and provide the needed support and
training for their staff. Challenges such as budget, lack of support from stakeholders,
values, employee attendance, high turnover rates, and employee morale all play
a huge part in the everyday management of a healthcare facility. (Kabene, et. al,
2006). A solution to these challenges could be found through coordination of
patient care and interdisciplinary teamwork (Kirby, 2002). According to Kabene,
“Since all health care is ultimately delivered by people, effective human resources

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management will play a vital role in the success of health sector reform” (Kabene,
et. al, 2006).

6.5 MANAGEMENT AND HUMAN RESOURCES


Employees are often considered the most valuable part of any healthcare
organization in which a manager should invest. As Niles writes, “To develop a well-
organized and competent workforce, the human resource management in health
care organizations should provide constant improvement in such areas as job
analysis and recruitment, legal and ethical management framework, health career
promotion, distribution of employee benefits, motivation and support, and future
trends in employees development” (Niles, 2013, p. 17). The partnership between
the human resources department and management of an organization is often
unique in the healthcare setting—including nursing—because many healthcare
organizations are built on a multi-level managerial structure (Niles, 2013). For
instance, the roles of clinical managers versus supervisors are sometimes confused.
The clinical manager is responsible for the different aspects of a particular clinical
setting, while a supervisor may be responsible for the entire unit. Human resources
management often helps to bridge the gap between the different areas of healthcare.
One of the most important aspects of human resource management in
healthcare is defining the ethical codes of conduct for the employees of a healthcare
facility. Ethical codes of conduct must be developed for all healthcare facilities in
order for employees to cope with moral dilemmas and conflict situations in the
most efficient way. Many state and federal laws have been put in place to protect
healthcare workers and patients. This legislature is often the foundation of the
safety and welfare of healthcare facilities. The human resource’s manager or
department is responsible for laying the foundation for efficient standards that
lead to a safe environment for all healthcare teams’ members and patients.
Job analysis and design is also a foundational aspect of human resource
management. Job design describes a set of duties and tasks that an employee will
be required to complete in the workplace setting daily, while job analysis is the
assessment of these skills performed by the employee. In order for the employee
to be successful and continue to grow, job analysis from the human resources
department or from the employee’s manager is imperative. In turn, this process
leads to efficient problem solving and decision-making skills by the employee.

6.6 MANAGING CONFLICT IN THE WORKPLACE


How conflict is handled in the workplace can make a difference in how employees
feel about the organization moving forward. Human resource professionals
are often given the task of handling or mediating employee issues. Along with
managing these difficult situations, human resource professionals are also tasked
with providing a solution to these issues that everyone can agree upon. You can
probably imagine that finding a creative and strategic way of handling employee

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conflict on a daily basis cannot be easy. Forbes Human Resource Council (2018)
recommends that allowing both parties to be heard, remaining transparent in the
decision-making process, and finding a solution that makes both parties happy
can make human resource management personnel better equipped to handle
workplace conflict. The Forbes Human Resource Council (2018) recommends the
following 14 strategies for mediating conflict resolution between employees:

1. Go in with an open mind


2. Be an advocate
3. Ask authentic questions
4. Remember you are the solution
5. Understand interpersonal effectiveness
6. Hear everyone out
7. Encourage open communication
8. Genuinely care
9. Help parties come up with their own solutions
10. Do not overcomplicate it
11. Reframe the situation
12. Stay focused
13. Follow up post-meeting
14. Coach for healthy conflict (Forbes, 2018).

There are no universal laws for managing workplace conflict. Every conflict
has its own unique situation and outcome. Human resource professionals need to
involve all parties in the conflict resolution process. Good working relationships
often lay the foundation for successful companies, but even good working
relationships are not always perfect. The overall goal of conflict resolution is to
build a common ground to arrive at a solution for each conflict.
When conflict is allowed to go unresolved, it leaves employees and managers
in a negative place. Not addressing conflict ultimately has a negative impact on
productivity and teamwork in the workplace. In the end, it is up to the human
resource management employees to determine the proper approach to addressing
each conflict. Often everyone involved in the conflict believes their solution is the
proper action. However, it is the human resource management team that must
develop an in-depth understanding of the situation and what that led to the conflict
in order to identify the possible outcomes that can help resolve the situation.
Ultimately, the goal of the human resource management team should be to reduce
or manage the conflict until a suitable resolution appears.

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6.7 EMPLOYEE RETENTION


Finding employees who have the skills needed to work in healthcare is not the
only challenge human resources management professionals face. Retention of
employees is also a major concern of workplace managers. Many human resource
professionals believe that it is easier to retain a qualified employee than to recruit,
train, and orient a new employee to the same workplace. According to the SHRM’s
Employee Job Satisfaction and Engagement “The Doors of Opportunity are Open”
research report, employees identify the following five factors as the leading aspects
of job satisfaction:

1. Respectful treatment of all employees


2. Compensation/pay
3. Trust between senior employees and management
4. Job security
5. Opportunities to use job skills at work

Retention of healthcare employees is often difficult in the healthcare industry


due to employee burnout. The healthcare industry is often considered a high-
pressured atmosphere that comes with many unexpected events each day.
Whether you are a nurse, doctor, physical therapist, or transporter in the hospital,
your daily schedule many never be the same, and your work hours are often more
than the normal 40-hour work week. Stories and data abound in regards to how
clinical practitioners and staff at all levels are feeling frazzled and overwhelmed at
hospitals, physician practices, clinics, and other healthcare organizations (White,
2019). According to White, “Between high patient loads with little time to provide
personalized care, dealing with data entry in electronic health records systems and
long, task filled shifts, many doctors and nurses are not only considering leaving
their current jobs, they are thinking of abandoning their career choice entirely”
(White, 2019, p. 2).
In many different job settings today, stress is abundant in the healthcare
workplace. This stress will always lead ultimately to job turnover and dissatisfaction.
White (2019) states that “in an industry where staff can make or break patients’
outcomes and experience, it’s key to boost your employee retention rates to keep the
best and brightest from burning out or quitting” (p. 4). White (2019) recommends
the following four factors in retaining employees in the health care workforce:

1. Recognizing achievements
2. Giving workers a purpose
3. Providing employees opportunities to relax
4. Creating a positive culture in your organization.

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Recognize
Achievement

Positive Employee Give


Culture Retention Purpose

Provide
Opportunities
to Relax

Figure 6.1: Four Factors for Retaining Employees in The Healthcare Workforce
Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

Employee satisfaction and engagement in the workplace are often the key
factors to employee retention. Imagine being in a job where your voice was heard
and you had a feeling of belonging and purpose. Would you be more willing to stay
in your environment and work harder? Would you stay in a job that did not value
you as an employee and only considered you as a number? In human resource
management, focusing on employee retention can lead to employee satisfaction,
increased morale and quality of work. In the long run, employee retention and
satisfaction pay off for the workplace: “The bottom line is that managing for
employee retention, organizations will retain talented and motivated employees
who truly want to be a part of the company and who are focused on contributing to
the organization’s overall success” (White, 2019, p. 1)

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6.8 COMPONENTS OF HUMAN RESOURCE


MANAGEMENT
As we discussed earlier in this chapter, human resource management is used
to describe the employees who work for an organization and the department
responsible for managing the resources related to an organization’s employees.
The term human resources was first coined in the 1960s when the value of
employees in an organization began to take root. In today’s corporate world,
human resources management involves overseeing everything that relates to an
organization’s human capital—not just the employees, but the management and
developments of all parties involved in the organization as well. Recruiting and
staffing, compensation and benefits, training and learning, labor and employee
relations, and organizational development can all be found in most human
resources management departments for any organization.
Human resource management has changed drastically over time due to the
many different areas that can be found in human resources. These different areas
or career titles appear in the graph below.

HR
Manager

Training and
Benefits
Development
Specialist
Manager

Human
Resource
Professionals

Recruiter Compensation
Specialist

Employment
Service
Manager

Figure 6.2: Human Resource Professionals


Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

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It is very common for human resource management professionals to possess


specific expertise in one or more of these areas.
Developing or administering training programs that increase the effectiveness
of an organization are also part of human resource management: “It includes the
entire spectrum of creating, managing, and cultivating the employer – employee
relations” (What is Human Resource Management, pg. 2). For most human
resource management departments, the following list is included in their daily
responsibilities:

• Managing job recruitment, selection, and promotion


• Developing and overseeing employee benefits and wellness
• Developing and enforcing personnel policies
• Prompting career development and enhancing job training
• Providing employee orientation
• Providing guidance for disciplinary actions
• Serving as the overseer of job site accidents or injuries and completing
incident reports (What is Human Resource Management, pg. 2).

Along with overseeing each of the items above, the human resource management
department must also be available to address employee concerns, help with the
recruiting of new employees, oversee the employee separation process, and help to
improve morale inside the organization.
Today’s human resource management team is responsible for so much more
than just managing people. In August of 2014, Forbes described the shifting
changes and challenges in today’s human resource management teams. The article
discussed that human resource management teams must be able to communicate
the vision and mission of the organization in order to have an impact on its
organization and employees. Forbes (2014) suggested that the human resource
management team of the future must focus on the following five critical areas:

1. Define and align organizational purpose: An organization’s


employees must be able to communicate the mission and vision of the
organization. They must also understand how their efforts align with the
organization’s purpose.
2. Recruit the best talent: An organization must find an employee who
has not only the skills needed to complete the job but also the personality
and teamwork skills that will align with the current organization’s team.
3. Focus on employee strengths: Organizations must understand
what their employees do best and put them in positions where they can
use their strengths.

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4. Create organizational alignment: An organization’s achievements


must align with its objectives.
5. Accurately measure the same things: All departments within the
organization must measure the same things in order to establish definite
organizational results (Forbes, 2014).

6.9 ALIGNING HUMAN RESOURCE STRATEGIES


WITH THE HEALTH CARE WORKFORCE
In order for health care management to work in a health care setting, human
resource managers must align themselves with health care workers. Pastore &
Clavelle (2017) claim that as health care systems change, the synergy in practice
between human resource professionals and health care workers is an essential
function of an organization’s success. Let’s consider Florence Nightingale,
who wrote the Nightingale pledge for nurses. In 1854, while delivering care for
British soldiers, Nightingale observed the overcrowded and unclean conditions of
the military hospital. She used her observations to educate her fellow nurses in
developing ways in which to improve the hospital environment for these soldiers,
which in turn led to decreased infections and mortality rates. Nightingale used
her care and compassion for these soldiers to better the outcomes of the hospital
facility in which she served.
The relationship between human resource professionals and health care
workers in the hospital setting is integral in allowing patient-centered care:
“Organizational measurements on employee retention, management effectiveness,
communication, and work-life balance can be traced to the early scientific analyses
and experiments of Mayo and Nightingale” (Pastore & Clavelle, 2017, p.1). This
partnership between health care workers and human resource departments lead
to a strong and positive workforce.

6.10 IMPLICATIONS FOR COMPLIANCE


Human resource management and compliance is imperative for any
organization to be successful. As discussed above, human resource management
is often involved in the hiring and firing of employees, but the human resources of
any organization also play a key part in the organization’s compliance structure.
Many different regulations and laws govern employment and employer-employee
relations. A few of these procedures appear in the chart below.

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Law or Regulation Interpretation


Uniform Services Employment Gives certain rights to employees who are called to
and Reemployment Rights Act active duty.
(USERRA)
Family and Medical Leave Act Gives employees the right to 12 weeks of unpaid
(FMLA) leave each year, under special circumstances, with
the right to return to the same or an equivalent
position upon returning from the leave.
Fair Labor Standards Act Defines minimum wage and overtime pay for
certain workers.
Table 6.1: Regulations and Laws Related to Human Resource
Source: Original Work
Attribution: Sarah Brinson
License: CC BY-SA 4.0

6.11 SUMMARY
Human resource management is a term that many different organizations
use to describe the management of employees within an organization. Human
resource management can include many different things within each organization,
including the on-boarding and off-boarding of employees, employee benefits,
employee training and education, the organization’s compliance internally and
externally, as well as conflict resolution. Today’s human resource management
team is responsible for so much more than just managing people. The relationship
between human resource professionals and health care workers in the hospital
setting is integral in allowing patient-centered care. Likewise, human resource
management and compliance is imperative for any organization to be successful.

6.12 DISCUSSION QUESTIONS


1. Describe the management of different types of healthcare professionals
in the workforce.
2. List three ways to manage conflict in the work setting.
3. Identify three ways to retain employees in the work setting.
4. Define and describe the different components of human resource
management in the workforce.
5. What are some human resource strategies that can be incorporated
into the workplace?

6.13 KEY TERM DEFINITIONS


1. Management- the process of running or controlling an organization or
institution.

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2. Human Resources- the department of an organization that handles the


on boarding, off boarding, administration, and training of personnel.
3. Health Care Workforce- the workforce that is responsible for health care
in hospitals, doctor’s offices, and all other medical facilities.
4. Conflict- disagreement or argument.
5. Employee Retention- the ability of an organization or institution to
retain its employees.
6. Employee Laws- defines employees’ rights and obligations within
the employer-employee relationship, wages, workplace safety, and
discrimination.
7. Employee Regulations- regulations in statute law that establish
minimum standards relating to the employment of persons, minimum
working age, and minimum hourly wage.

6.14 REFERENCES
Efron, L. (2014). What Organizations Need Now from Human Resources. Forbes.
Retrieved from: https://www.forbes.com/sites/louisefron/2014/08/18/what-
organizations-need-now-from-human-resources/#18c16d33173f
Forbes Human Resources Council (2018). 14 ways HR professionals can solve workplace
conflict efficiently. Received from: https://www.forbes.com/sites/forbeshumanreso
urcescouncil/2018/04/10/14-ways-hr-professionals-can-solve-workplace-conflict-
efficiently/#5a827a6c1250
Human Resource Edu. (2019) What is Human Resource? Retrieved from: https://www.
humanresourcesedu.org/what-is-human-resources/
Kabene, S., Orchard, C. Howard, J.. Soriano, M., & Raymond, L. (2006). The importance
of human resources management in health care: a global context. Human Resources
for Health. 4(20), pg. 1-17
Kirby, ML. (2002). The health of Canadians – the federal role. In the Senate of
Government of Canada Volume 6.
Niles, N. (2013). Basic Concepts of Human Resource Management. Burlington. MA.
Jones & Bartlett Learning.
Pastore, G. & Clavelle, J. (2017). Healthcare HR and Nursing Leaders: Synergy in
Practice. Healthcare Source. Retrieved from: http://education.healthcaresource.com/
healthcare-hr-nursing-leadership-synergy/
SHRM. (2017). 2017 Employee Job Satisfaction and Engagement: The Doors of
Opportunity Are Open. Retrieved from: https://www.shrm.org/hr-today/trends-and-
forecasting/research-and-surveys/pages/2017-job-satisfaction-and-engagement-
doors-of-opportunity-are-open.aspx

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White, J. (2019). Employee Retention in Health Care: 4 Keys to Keep Your Best and
Brightest. Retrieved from: https://www.hrmorning.com/articles/employee-
retention-healthcare/
World Health Organization: World Health Report 2000. Health Systems: Improving
Performance. Geneva 2000. Retrieved from: http://www.who.int.proxy.lib.uwo.
ca:2048/whr/2000/en/

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7
7.1 LEARNING OBJECTIVES
Healthcare Technology

1. State the impact of improved medical technologies.


2. Explain the use of decision support tools for healthcare organizations.
3. Discuss the process of implementing an electronic health record in a
healthcare organization.

7.2 INTRODUCTION
Rapid progress has been made to bring technology and the use of technology
into the healthcare setting. Patient information can now be shared between
providers, facilities, patients, and many organizations through the use of technology
and electronic health records. Using technology not only improves the quality of
patient care and efficiency but also can help in lowering the costs of healthcare. This
chapter will discuss various topics as they relate to technology, including patient
safety and quality while maintaining compliance within healthcare settings.

7.3 KEY TERMS


• HITECH Act
• EMR/Meaningful Use Data
• Data Security/Privacy of Information
• Interoperability & Interfaces  
• Decision Making Support Tools
• Order Entry Systems
• Telehealth

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Health Information Technology plays a vital role within the nation’s quality
strategy to achieve better care at lower costs along with healthy individuals and
communities because advancements in technology enhance improving both
patient safety and quality of care. In order to progress with better care and lowering
costs—with technology—policies, regulations, and many programs are used to
help transform healthcare. One policy we will discuss here is the 2009 Health
Information Technology for Economic and Clinical Health Act (HITECH). The
main goal of this act was to promote the adoption of health information technology
and meaningfully use technology, the support for which it specified three phases of
meaningful use (MU) for the nation’s healthcare to achieve improved quality and
patient outcomes. The Center of Medicaid and Medicare offered to give incentives
to encourage providers and hospitals to adopt and use certified technology. In the
U.S., the 2009 HITECH provided up to $26 billion in payments for hospitals and
ambulatory clinics to purchase electronic health systems with clinical decision
support (CDS) tools (American Recovery & Reinvestment Act, 2009). In addition
to the federal mandate, organizations were required to meaningfully use electronic
health records (EHR) technologies.

HITECH Act

Focal Hospital

EHR Quality Improving Process

Clinical
Clinical Quality of
EHR Use Workflow
Workflows Care
Performance

Physicians’ Hospital
Resistance to Settings
IT

Figure 7.1: HITECH ACT


Source: Original Work based on Lin, Lin, & Chen, 2019
Attribution: Corey Parson
License: CC BY-SA 4.0

7.4 MEANINGFUL USE (MU)


In order to achieve the national strategy, the HITECH act (as noted above)
specifies three phases of MU for the nation’s healthcare to achieve improved quality
and patient outcomes. Within each phase, advancements are made according to

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what is required from the capability of the technology. The table below delineates
these phases, according to the Office of the National Coordinator for Health
Information Technology (2018).

Stage 1 Stage 2 Stage 3

MU Criteria Focus on MU Criteria Focus on MU Criteria Focus on


Basic Data Capture and Advancing Clinical Improved Outcomes and
Sharing Processes Interoperability
Electronically capturing More rigorous HIE Improving quality, safety, and
health information in a efficiency, leading to improved
standardized format health outcomes
Using the information to Increased requirements Decision support for national
track clinical conditions for prescribing and high-priority conditions
incorporating lab
results
Communicating the Electronic transmission Patient access to self-
information for care of patient care management tools
coordination processes summaries across
multiple settings
Initiating the reporting More patient- Access to comprehensive
of quality measures and controlled data patient data through patient
public health information centered health information
exchange
Using information to Improving population health
engage patients and
families in their care
Table 7.1: Meaningful Use Information
Source: Original Work
Attribution: Laura Gosa
License: CC BY-SA 4.0

As we see from this chart, the first phase focuses more on the implementation
of electronic health records and using the system to prescribe medications—
electronically send prescriptions to pharmacies—and the ability to report quality
data. The second phase focuses on patient engagement and the ability of the
electronic health record to exchange data. The third phase focuses on value-
based programs to achieve quality care and on supporting population health
management. Throughout this MU program, hospitals and providers were
financially incentivized with payments from the Centers for Medicaid and Medicare
(CMS) if they implemented electronic health records and met the standards for MU.
Additionally, there were disincentives in terms of payments for failing to reach MU.
Starting in 2011, the incentive program continued over several years. As of April

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2017, CMS had provided incentives for more than 523,000 eligible providers and
to more than 4,900 hospitals with approximately $39 billion paid (CMS, 2018b).  

Think About This Scenario

A seasoned provider has been using paper charting for his entire career in
healthcare. Now, he has to learn the computer system for documentation and
also the mandated requirements for MU to avoid penalties in payment from the
CMS. He gets frustrated and so states that he “will stay on paper charting and the
government cannot tell him what to do.” His practice is in a large healthcare system.
When reports are analyzed on the providers meeting the requirements, his name is
on the list of “not meeting” requirements. How should the healthcare organization
handle this? Should he be provided a scribe to help with his documentation? Should
the organization offer to reduce his appointment schedule and have someone work
with him one-on-one so he is more confident in using the EHR?   

7.5 PATIENT SUPPORT TOOLS/DECISION


SUPPORT TOOLS
One goal in particular to the meaningful use component is the implementation
of tools that can guide providers in making appropriate decisions in patient care.
These tools are called decision support tools. According to Campbell (2013), clinical
decision support (CDS) is defined as a process to enhance health-related decisions
and actions with pertinent, organized clinical knowledge and patient information
to improve healthcare and healthcare delivery. These tools include reminders,
alerts, clinical guidelines, diagnosis specific order sets, patient summaries,
documentation templates, and referencing information (Greenes, 2014). The
Institute of Medicine has recognized problems with the quality of healthcare in
the U.S., and so advocates for the use of technology to improve quality patient care
with such CDS tools (Sheroff, 2012). One goal in particular to the MU component
is the implementation of tools that can continue to guide providers in making
appropriate decisions in patient care. These tools are called decision support tools.
According to Campbell (2013), clinical decision support (CDS) is defined as a
process to enhance health-related decisions and actions with pertinent, organized
clinical knowledge and patient information to improve healthcare and healthcare
delivery. These tools include reminders, alerts, clinical guidelines, diagnosis
specific order sets, patient summaries, documentation templates, and referencing
information (Greenes, 2014). They help providers reach a proper diagnosis, ask
the right questions, perform appropriate tests, prevent errors, reduce costs, and
promote quality (McCool, 2013). CDS provides support at various stages of care,
from the preventative phase all the way through the diagnosis phase, treatment
phase, and monitoring and follow-up care phases (Berner, 2009). CDS intends to
make data easier to understand, foster problem solving, process data, and assist

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providers in providing quality care. Many forces drive the implementation of CDS
tools in a clinic, including the following: lack of a reference database within the
application to facilitate providers in decision making, poor patient engagement
with their healthcare, medical errors, lack of quality care, an increasing aging
population with complex diagnoses, redundancy of tests, poor efficiency in
workflows, high costs, and poor coordination of care (Greenes, 2014).
According to Greenes (2014), the efforts to stimulate the adoption of CDS
depend highly on local needs and user preferences in many organizations, leading
to difficulty in acquiring and little benefit in possessing CDS knowledge and
experience. Rethinking the way our healthcare organization is structured needs
our not only adopting CDS tools but also restructuring the information technology
to support it—in order to achieve patient-centered care while focusing on wellness
and to coordinate care processes (Greenes, 2014).   
Also according to Greenes (2014), better informed decisions can lead to
better patient outcomes. To facilitate this clinical decision making, information
resources must be integrated into information systems. As clinicians use this built-
in information, better decisions can be made regarding patient care. Additionally,
clinicians will use information buttons (“I”) as a point of care access to knowledge
which will also automatically select and retrieve information from knowledgeable
resources (Greenes, 2014). Integrated into the electronic medical record (EMR),
the info button links can anticipate the information needs and also initiate the
retrieval of information. Although it is available, it can be time consuming for
providers to search for this information, which can be located within the areas
of medication lists, problem lists, diagnosis areas, and orders areas. Further, to
ensure MU adoption and their use of these buttons, they are included in every
clinical guideline and quality measure (Cimino, Jing, & Del Fiol, 2012).
Other forms by which providers gain access to patient information within
their organization’s systems include the Epocrates monograph, which assists the
provider and staff with more information on medications. UpToDate systems also
compile information from experts who can assist with answering clinical questions.
And apps on electronic devices assist providers with locating information as well.
Alerts are the most common form of CDS tools (Souza, Sebaldt, Mackay, Provok,
et. al, 2011). Examples of end user tasks include the following: alerts, text messages
and direct messages, notifications, and reminders within the system that alert the
end user if an action is required. Medication alerts are extremely useful in offering
a method to decrease adverse reactions. When medication orders are placed into
the system, an alert can pop up for the provider if there is a contraindication or an
incompatible medication. Alerts for patient quality measures are also extremely
useful. For example, the patient may be due for a colonoscopy, so the system will
alert the end user based upon the patient’s age and the quality measure that the
provider is using.
Such notifications and reminder tools are extremely beneficial to the healthcare
organization. They could notify or remind the patient when it is time for a flu shot

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or to make an appointment with the provider; also, they can relay messages from
the organization to the patient, including about outreach campaigns and health
screenings. Notifications or reminders for the staff are considered part of the end
user tasks, for example, with the user receiving a task that needs action, such as
the notification that a patient’s quality measure is due. However, if there is an
impact to the provider’s workflow or their time, CDS can lead to workarounds,
ignoring warnings, and fatigue from their having to click through the alerts
(Greenes, 2014). While such issues exist regarding alerts and reminders, many
issues involve bypassing overrides. The system intends to assist with decision
making; nevertheless, there continues exist many providers and staff who will
ignore warnings within it.
According to Greenes (2014), CDS is a useful tool to apply medical knowledge
to achieve great organizational performance. Greenes (2014) also discusses the
CDS Five Rights, including that the right information must be presented to the
right people, in the right formats, through the right channels and in the right
points of workflow.
The organization must continue to optimize the deployment of CDS for
maximum benefit and for the acceptance of its being utilized by the users (to avoid
the problematic issues above). Greenes (2014) states that organizations should
shift from viewing CDS as a built-in functionality within the system to viewing
CDS as an added value that is incorporated into systems.

Figure 7.2: Clinical Decision Support Tools


Source: 123rf.com
Attribution: User “aurielaki”
License: aurielaki © 123rf.com. Used with permission.

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7.6 CLINICAL DECISION SUPPORT SYSTEMS


As noted above, the 2009 HITECH Act provided up to $26 billion in payments
for hospitals and ambulatory clinics to purchase electronic health systems with
CDS. In addition to the federal mandate, organizations must meaningfully use the
electronic health records (EHR) technologies, including through CDS interventions.
CDS interventions can fall into one of four categories: data entry, data review,
assessments, and triggers by end user tasks (Baker, 2013). Data entry includes
smart forms and order sets that the system can use to help facilitate quality and
improve efficiency for providers. Smart forms are an easy to use diagnostic and
documentation tool that is especially useful to providers (Greenes, 2014). An
example of smart forms within a system are flow sheets that allow the providers to
look at results, vitals, and other pertinent data that can facilitate decision making
over a period of time. These forms are easy to print and can also be used to graph
the data that can be meaningful to the patient. Order sets are another example of
data entry CDS intervention that can be particularly useful to providers. These
ordering sets can be built by the providers or an informatics nurse who can generate
a complete list of orders based upon a patient’s diagnosis. Order sets are especially
useful and also very efficient for the provider, saving them the large amount of time
required to enter in many various orders.
Data review is a second form of CDS intervention and includes such items as
reviewing accurate problem lists, medication monitoring, accurate allergy lists,
critical results tracking, medication decision support, quality and clinical guideline
measuring, and lab and imaging reviews. Within a medical clinic, having a detailed
problem list and medication list can facilitate the provider’s decision making,
especially when placing orders. Having the capability to review results within the
system and having the results of both lab and radiology interfaced back into the
system can assist with providing quality of care and can help to reduce costs. These
results can be placed in a color-coded system (red, yellow, green) that will alert the
provider if the results are critical, normal, or abnormal. In addition to reviewing
the data, the assessment of the data is a vital component of CDS intervention to
providers.
CDS tools that can foster the assessment of data for providers include
information or referencing material, letters, and educational handouts for
patients. Information and referencing materials are extremely useful for providers
to look up various diagnoses, treatments, and medications to provide quality
care for their patients. These materials can be populated within the application
in the form of an information button, which the providers can click to search
for anything related to patient care. Letters are another CDS tool that fosters
assessment and understanding. Letters can be generated within the system and
faxed to the patient’s primary care provider, specialists, or other providers that
are a part of the patient’s care team. This facilitates care coordination and allows
the providers to communicate their findings based upon the patient’s visit. Letters
can also be sent to the patient’s email using a patient portal system that can help

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engage patients in their care and keep them informed. Education handouts for
patients are a component of meaningful use (MU) and are required by the provider
to meet the MU measure. These handouts can be automatically populated by the
computer based upon the patient’s diagnoses or medications that are placed into
the system by the provider. This function also allows patients to read and become
more engaged in their care.
Lastly, such clinical professionals’ tasks as alerts, text and direct messages,
notifications and reminders are important CDS tools that would be extremely useful
to patients, particularly in alerting their medical professionals that an action is
required. Again, such alerts offer methods to decrease adverse reactions and foster
patient quality measures. A huge component of these important alert systems is
closed-loop ordering, which is where a provider can place an alarm on lab and
imaging orders within the system. If the result does not return back to the system
within the alarmed time frame, it will fall into a category of a “needs follow-up”
so that the provider can investigate why the result did not come back. Often, it is
secondary to patient non-compliance where the patient did not have the test or lab
performed. Vaccine alerts are another useful CDS tool in which the provider can be
triggered when it is time for the patient’s vaccine. It is also useful if these vaccines
are then interfaced with the vaccine registry system so that it is automatically
updated and stays current.
As noted above, text and direct messaging are vital and beneficial alert CDS
tools. They allow the provider to send a secure text message or a direct message
via a secure email. Vital information can thereby be sent to facilitate the patient’s
care coordination, send consult notes to specialists, transfer care documentation
between facilities, and foster communication between providers to enhance patient
care.
Similarly, notifications and reminder tools for the patient or the end users can
be beneficial to the clinic, as noted above, for such quality care measures as flu shot
and appointment reminders. Also, the relay messages from the clinic to the patient
regarding outreach campaigns and health screenings can be vital to ensuring
increased patient care. Such notifications or reminders for the staff are considered
part of the end user tasks. According to Carney, Morgan, Jones, McDaniel,
Weaver, & Haggstrom (2014), such CDS alerts have significant impacts on cancer
screening strategies which were improved using CDS alerts in community health
centers. Patient engagement is considered a cornerstone for high-quality healthcare
and can improve health outcomes for patients while reducing healthcare costs (Al-
Tannir, AlGahtani, Abu-Shaheen, 2017).
Overall, CDS tools are extremely useful to improve safety, quality, care
coordination, decrease medical errors, improve efficiency, and reduce costs
(Sheroff, 2012). As Greenes writes (2014), there may be a significant cost savings
when implementing CDS tools, especially if these tools fit well into clinic workflows
and target gaps in healthcare.

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7.7 TELEHEALTH
Telehealth refers to a range of health services that are delivered by
telecommunications, such as through the telephone, videophone, and computer. The
American Telemedicine Association defines telemedicine as “the use of medical
information exchanged from one site to another via electronic communication to
improve patients’ health status” (ATA, 2010). The Mayo Clinic expects to serve
over 200 million patients by 2020 using telehealth technologies (McGonigle &
Mastrian, 2018). When information can be collected at home—through telehealth,
for example—it can become more convenient for the patient and more productive
for medical professionals. Telehealth can be used for patients with chronic
conditions, at-risk patient populations, isolated patients, incarcerated patients,
hospitalized patients, emergency response situations, home health patients, and
employers and wellness programs.

Example

Think about a patient who has just been discharged from the hospital with new
medication and a diagnosis of congestive heart failure. The home health nurse
visits the patient twice per week. A home telemonitoring system was placed and
tracks and transmits the patient’s vital signs and weight. When abnormal data is
detected in the system, the home health nurse can be alerted quickly and prompt
a phone call to the patient. Also, the nurse can quickly contact the physician.

Telemedicine can prompt quick response times with early detections and timely
interventions for patients. Research has shown that telemedicine can decrease
patient hospitalizations and emergency room visits (Totten, 2016). However,
telemedicine can also pose some compliance issues. A healthcare provider must be
licensed in the state in which they are providing telehealth services and interacting
with patients. Patients must also give informed consent to receive telehealth
services and must understand the intrusiveness of in-home monitoring.

7.8 STANDARDIZED MEDICAL LANGUAGE


As the federal government pushes for healthcare organizations to adopt
the use of electronic health records, there is a great need to have standardized
languages between the systems. In order to facilitate accurate reporting, accurate
data analysis, data extraction, and data sharing, many health systems work
through interface messaging systems to map necessary data that may not equal
each other. Having a standardized medical language within the systems allows for
enhanced data sharing, which leads to evidence-based practice. In addition, when
standardized languages occur between systems, the messages are easy to interpret
and translate the data into meaningful pieces of information to other accepting
systems. If standardization does not occur between systems, the messages would

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not be meaningful and the data could not be analyzed in a useful manner. Sharing
data is crucial for the health of our patients. The sharing of data, therefore, must use
standardized languages to facilitate the same meanings to downstream systems.

Think About This Scenario

A patient is seeing his primary health provider. The provider orders lab testing
and also wants to refer the patient to a gastroenterology group for a colonoscopy,
due to the patient’s age, and this quality measure is populated on his electronic
health record. The staff proceeds to draw blood for the lab work and the patient
is told they would hear from the gastroenterology providers in regards to an
appointment. Technology has now made it possible for the patient’s lab results
to be electronically sent back to the provider via the electronic health record,
link up to the patient’s chart, and also alert the provider for any abnormal
results. The provider can also send the patient’s progress note electronically to
the gastroenterology group so they can follow up with the patient to schedule
an appointment. Once the appointment is made, they can send a message to the
provider.

Through the HITECH Act, this process was made possible. Such techniques
streamline the chain of action so the provider can focus on the quality of patient
care.

7.9 IMPLEMENTING AN ELECTRONIC HEALTH


RECORD
The implementation of an EHR involves many benefits, including the
following: improved efficiency, improved accuracy when performing tasks,
immediate availability of patient records, and lower operational costs. Successfully
implementing an EHR is more than just selecting a vendor and signing a
contract. Project teams must be formed, organizational goals should be specific
and acknowledged, and an implementation plan should address everything
from hardware, workflow, training, and the required software for everyday
tasks. Consequently, the process of selecting and implementing an EHR can be
overwhelming if careful planning does not occur.
The selection and implementation process involves a great deal of time and
costs, so the selection of an EHR should not be taken lightly. Many deciding
factors should go into choosing the most appropriate one for the organization.
The deployment of an EHR is not always just about the technology pieces that are
involved. It also means finding an EHR that will assist the organization to reach
their business objectives (McCarthy & Eastman, 2010).
Careful considerations should include the capability of the EHR to meet all of
the MU requirements and appropriate safety standards as well as to offer quality

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measures, the best patient care standards, and solutions to the efficiency and the
productivity of providers. When selecting an EHR, appropriate stakeholders in an
organization should be involved. This step will save time and money when various
vendors come to demonstrate their product to the organization. Of course, not every
stakeholder has a lot of time to sit and listen to various demonstrations, so it is
very important for analysts and information staff to research a few vendors before
bringing them to demonstrate the EHR to only the stakeholders who would be
involved with making the final decision from the selection.
In addition to managing the time involved during the selection process,
managing time during the implementation process of the project is important
as well. Developing a schedule is important when managing time during the
implementation of the project. Scheduling requires some decision making on tasks
to be done, the responsible party to perform the tasks, the time involved in the
tasks, and any sequencing of the tasks that need to occur (Shirley, 2011). As already
mentioned, stakeholders’ schedules are an important part of managing time. They
should be involved in the project, but their time should be respected, for instance,
by not asking them to attend every meeting. Matching the project’s tasks to the
appropriate individual with the best skill set can be an important factor with
timing. If this process does not occur, it may take an individual longer to complete
tasks; it may also lead to inaccuracies. If a person with the appropriate skill set is
not available, then extra costs to bring in consultants to help perform the task may
be incurred (Shirley, 2011). Other time considerations include the sequencing of
the tasks needing to be performed. This is important because it can cause a delay
in the deployment of the project if certain tasks have to be completed before other
tasks can begin. Careful planning, therefore, should occur, and each person should
be held accountable for completing their tasks.
Taking the time to plan appropriately is important to the project’s success and
maintaining the project’s timeline. Carefully analyzing the organization’s workflow
in the beginning phases of implementing an EHR can save time and money as
the project continues to move forward. Every job in the organization must be
analyzed to look for opportunities for improved efficiency—which may require
some redesigning of workflows—so that the tools within the EHR can be used and
maximized to its full potential. Managing costs are important when implementing
the project as well.
The purchase of an EHR can be costly; however, the benefits can be worth the
financial investment and can save money in the long run if managed correctly.
Studies estimate the costs of purchasing and implementing an EHR range from
$15,000 to $70,000 per provider (Fleming, Culler, McCorkle, Beckler, & Ballard,
2011). Each system may vary in the costs of the EHR. Besides the initial costs of
purchasing the EHR and the time involved when selecting the EHR, other costs
include hardware implementation, training, and maintenance costs. Some systems
require organizations to pay per licensed user, some require a subscription with
monthly charges, and others may charge a percentage per billed dollar amount.

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It could seem favorable for an organization to go with the least expensive EHR
software; however, this option may not be suitable for the practice and could end
up costing more in the future. Consequently, developing a budget for these costs
is important to determine if the project is on track. Estimating costs requires a lot
of consideration of the project’s resources, including people, materials, and the
equipment needed to complete the project (Shirley, 2011).
In addition to the costs of the hardware and software, other costs to consider
include paying for additional resources to come and offering training to staff. In
a large organization, it may be suitable to pay appropriate consultants to offer
training and support within the clinic on “go live” day. Also, data abstraction is
a huge cost factor, especially for the clinics that are on an existing EHR and are
changing to a different one. Entering in old patient data involves a lot of time. Costs
can occur with data abstractions when decisions regarding who will preload the old
existing data within the company arise, and may also ensue when hiring a data
abstracting company to assist should extensive data abstraction be necessary. In
addition to managing time and costs, project management also supervises quality.
According to Shirley (2011), project management, overall, is managing quality.
The integration of health information is critical to provide quality care in today’s
fragmented health system. The EHR is a tool to facilitate quality, but it must be used
correctly and to its full potential in order to do so. Otherwise, the stored information
can become too cluttered and the providers will overlook it (Gill, 2004). The lack
of real time information can result in delayed treatments, uninformed decisions,
and medical errors. EHRs that have the capability to support disease registries
and identify patients who need follow up care can report or audit to assist with
managing quality through using work dashboards and facilitating a team approach
to increase patient participation—all of which is important to managing patient
care quality. However, whether it is the product’s capability to manage quality or
the quality of the project management process, quality itself is one of the most
important tasks (Shirley, 2011).
Clearly, the selection and implementation of an EHR can be challenging.
However, with good planning, strong physician leadership and involvement, and
openness to change, the process can become less cumbersome (Smith, 2003).
Managing time, costs, and quality are the most important factors for success with
the overall project.  

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Figure 7.3: Electronic Health Record


Source: Wikimedia Commons
Attribution: User “DaCarpenther”
License: GNU General Public License

7.10 SECURITY
Security will continue to be an ongoing challenge in today’s environment. As
fast as new security measures can come out, hackers are quick to find ways
to spread viruses and hack into the systems, so breaches in data still can be a
problem. Many health systems thus utilize tools to monitor staff use and detect
any breaches in data or confidentiality issues. Employees sending protected
information via email must send it as an encrypted document. Each system
used in the health system should have security measures requiring changing
passwords within so many days. The computers and laptops have log off
features, and many organizations have the policy to “control alt delete when you
leave your seat.” This phrase means to lock the screen or log off when walking
away from the computer. Another concern that many healthcare organizations
continue to have is nursing staff and providers’ leaving the pull-down computers
in the hallways open when they enter a patient’s room so that anyone passing
down the hall may view the charts. Managers must hold staff accountable if
this incident occurs. For security, staff and providers are locked out of systems
or roles are changed as needed when employees are terminated or transferred
to other departments within the organization. Many organizations also have a
data breach plan in the event that a data breach occurs. The rise in using EHRs

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has also caused security management to not keep up with the pace of healthcare
data (Kwon & Johnson, 2018).
While the Health Insurance Portability and Accountability Act (HIPPA) was
already in place, the HITECH Act also emphasizes the importance of data security,
especially with exchanges in health information (Gold & McLaughlin, 2016).

Think About This Scenario

You are visiting your healthcare provider and the nurse is documenting your
information into the computer system located inside the patient exam room. She
then tells you she needs to go work up another patient and the doctor will be in
shortly. She leaves the computer up with another patient’s information displayed
on the screen and you are able to view it. This is a huge HIPPA violation.
Here is another scenario: A patient visits the health care provider and the nurse
clicks on the chart in the EHR but accidentally clicks on a different patient and
does not realize it at the time. The doctor also sees the patient and begins to
order some tests, labs, vaccines, and sends prescriptions electronically to the
pharmacy via the system. Two days later, results come in for a patient that
are abnormal, and the provider realizes that the patient was not seen and a
different patient’s chart was documented by accident. Years before electronic
documentation, the paper chart could be removed easily and this mistake could
easily be taken care of. Now, with the use of technology, the chart must be
cleaned up. The pharmacy has to be notified and the patient has to be called
to make them aware of the situation. The lab will need to be notified so the
patient’s results can to go into the correct chart. Not only will the chart within
the healthcare organization need to be corrected but also the Georgia Registry
of Immunization Transactions and Services (GRITS) will have to be notified and
corrected because the vaccine registry was electronically sent via the EHR on
the incorrect patient. If the patient had reminders or alerts scheduled on the
patient portal system, it could also go out to the incorrect patient. This error can
be a huge HIPPA violation in so many ways and also cause much stress when
getting all the information cleared up within every system. When dealing with
technology healthcare providers and staff must remain diligent to the chart they
are documenting in.

The risks of violating a patient’s privacy will always remain a concern when
dealing with technology in healthcare. Electronic charting will heighten the risk
of patients suffering the consequences of privacy breaches regardless of if such an
action is intentional or unintentional (Agris, 2014). Protective health information
should always be protected, and staff and providers must have extensive training
on the use of EHRs and protecting patient information.

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7.11 INTERFACES, HEALTH INFORMATION


EXCHANGES, AND HEALTH INFORMATION
ORGANIZATIONS
Interfaces enable a system to communicate and send messages to other
systems, usually from a system to downstream systems. For example, a local health
system has essentially two main systems; one is an EHR for ambulatory clinics,
and the other is used for inpatient care within each hospital. Each system has a
registration interface, a billing interface, and a document interface. Additional
interfaces include laboratory and radiology orders and results. Each system has a
patient portal interface where patients can log in and view their most recent clinical
documentation. Also, dictation interfaces move the dictation to the transcription
area and back into the patient’s medical record. And there are interfaces with the
Georgia Immunization Registry (GRITS) from each system to update vaccines.  

7.12 SHARING INFORMATION


Increased healthcare costs, higher population ages, and struggles in today’s
economy are key reasons the healthcare industry must make changes in the way
clinical information is shared (Jones & Groom, 2012). It is extremely important to
communities that healthcare organizations come together and have access to data
and shared information. Having a patient’s medical history available anywhere and
at any time is vital to support the health of our community. Indeed, the importance
of a health information organization (HIO) is extremely vital to communities. This
integrated data will help providers give a more holistic approach in patient care
and will also allow the patient’s big picture, health-wise, to be seen. Becoming
integrated will require some effort in technology adoption, standardization,
interoperability, privacy, and security in data exchanges to improve clinical and
health outcomes (Jones & Groom, 2012).
Systems innovation in delivering information and reimbursement has
increased stakeholders’ needs to implement an HIO (Pina, Cohen, Larson, Marion,
Sills, Solberg, & Zerzan, 2015). The continuous evolution of healthcare is why HIOs
are important. Healthcare is moving to a value-based payment system, which is
increasing the need to require health systems to integrate clinical data by pursuing
alliances and partnerships (Kizer, 2015). Reimbursement is not the only important
reason for the success of an organization to implement a HIO. Improvements in
healthcare quality, efficiency, and patient engagement through a HIO are also
important reasons for the success of an organization. Health care organizations
will need the technology to help reduce paperwork and unnecessary treatments as
well as decrease medical errors.
A robust infrastructure is required to support clinical integration (Strong,
2014). Many technical components are required to support data sharing.
Interoperability is vital so that organizations can use data by communicating

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and sharing the terminology and definitions of relevant data (Jones & Groom,
2012). According to Jones & Groom (2012), there are three types of interoperability:
technical, process, and semantic.
Technical interoperability refers to the hardware components needed to connect
across a network and applications through simple exchanges, simple exchanges
with a defined message, and complex exchanges. The technical pieces all work
together to make sure the data is streamlined and shared between systems. Some
of the components may consist of high speed, secure networks and the applications
that have the capability to exchange data.
Process interoperability is necessary for communication between the systems
to contain the appropriate data elements and to organize the data in a manner that
will be meaningful to the end user. This process can include such components as an
interface engine that sends data in a message format such as a health level 7 (HL7)
message that will reduce data uncertainty and improve information transmission
among all stakeholders. It can also include algorithms for patient matching and
enterprise master patient indexes to ensure the data is correctly matched to the
appropriate patient.
Lastly, semantic interoperability is vital for shared information. Jones &
Groom (2012) define semantic interoperability as the capability of information
shared to be arranged in an organized, sequential, and concise manner so that
it is understood by the receiver—rather like the picture of the puzzle once the
puzzle is put together. It can be sent in the form of a free text field; can be a form
of classification, such as International Classification of Disease Codes (ICD 9
codes), Current Procedural Terminology codes (CPT codes), Healthcare Common
Procedure Coding System (HCPCS), Systematized Nomenclature of Medicine
(SNOMED codes), and National Drug Codes (NDC codes); and it can be sent as a
blob of data elements that is meaningful to the end user or receiver.
Many key components are needed to implement the health information
exchanges (HIEs) and health information organizations. Data sharing agreements,
network access, interface engines and translations, record locator services, master
patient indexes, data repository, standards, interoperability, data privacy, and
data security are all necessary technical components for HIEs. Having all of
these components is vital to the success of HIOs and to an organization. So why
is there a great need to implement a HIO? To answer this question, one must
look at the many benefits this system will provide. These benefits include higher
quality and safe patient care, increased efficiency of providers, reduced costs,
reduced duplicated testing, and reduced adverse drug events; they also promote
better coordination of patient care and facilitate population health and disease
management. Improvements in quality by sharing data can save between $70 and
$80 billion annually (Centers for Information Technology Leadership, 2011).
Our nation’s mission to use health information technology for the
transformation of our healthcare system will be a challenging task. In order for the
financial and clinical benefits to be successful, stakeholders will need to implement

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various small projects to progress the overall larger goal of HIO statewide as well
as nationwide. As HIOs evolve, trust, collaboration, and communication are
fundamental to a successful implementation (Penafiel, Camacho, Aistaran, Ronco,
& Echegaray, 2014).
HIEs can provide various services specifically in Georgia. These services include
the following: data lookup services and matching the patient to the data; secured
data delivery and confirmation of the delivery; exchanging patient care summaries
among organizations, including tests and the results; sending immunizations to
the state registry; auditing data access and exchanging information; sending direct
messages to providers regarding patient care; administrative services for claims
and authorizations for treatments from insurance carriers; patient portals with
clinical messaging; emergency access capabilities,; and exchanging data for disease
management and community reporting. The goal is to have regional HIEs, then
state HIEs, followed by a national HIE. What does this all mean? Basically, many
health care organizations are partnering with regional health care organizations to
connect and make a regional HIE so that relevant data is shared. For example, if
you travel two hours south from where you live and get into a car wreck, the hospital
there will have your relevant data, such as your allergies and medication lists, so
as to treat you. As regions move forward with the development of HIEs, the state
will have one state HIE where all healthcare systems can share relevant patient
information for this same reason. It will be very similar to the GRITS platform
which houses the state of Georgia’s vaccines for patients. Lastly, the nation will
progress into a national HIE. For example, if you travel to California and get in
an accident and have no one with you to answer questions, the national HIE can
be accessed to view relevant information to take care of you at that time. Huge,
isn’t it? There are still, however, many problems being worked out for regional
levels before the HIE can progress to state and national levels. Having all of these
services can improve the coordination of patient care and ultimately reduce the
costs in healthcare. Clearly, HIEs are important for many reasons, but one main
reason is due to the opioid crisis we are experiencing throughout our nation.
Years ago, providers were unable to view patient’s information and would
have the patient bring their pill bottles with them to their appointments so the
providers could view what the patient was taking to document within their paper
charts. Currently, systems are set up to allow the interoperability between EHRs
and the Pharmacy Benefit Managers (pharmacy system) that will query and link
up to anything the patient has purchased from the pharmacy. These systems allow
providers to view medications accurately. However, there were some loopholes.
The PBMs would only populate the data if the patient paid using their insurance
card. So what do you think the patients who were seeking more medicine were
doing? They were going to pick up prescriptions for narcotics and paying in cash
so it would not be tracked. This practice led to huge workforce teams being placed
on a project to get this problem corrected. So currently, any scheduled medications
such as opioids will be placed into a database that can be viewed by any provider.

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Pharmacies have to document this information into the system to include the
patient name, date of birth, provider who prescribed the medication, when it was
prescribed, and when it was picked up by the patient. This process allows providers
to not prescribe a medication to a potential “doctor shopping” patient and to help
in lowering the overuse of opioids. All of these solutions were made possible by
technology and interoperability in healthcare.  

Local Health
Department
EHR

Community
Specialty Health Center
Physician EHR
EHR

HIE

Primary Care
Hospital Physician
EHR EHR

Figure 7.4: Health Information Exchange


Source: Original Work
Attribution: Corey Parson
License: CC BY-SA 4.0

7.13 IMPLICATIONS FOR COMPLIANCE AND


SUMMARY
As the healthcare system is driven towards a value-based system, the need for
better access to patient information and the ability to use and exchange patient
information is vital to improve quality and lowering patient care costs (Thorpe,
Gray, and Cartwright-Smith, 2016). Long gone are the days when paper charts
were being utilized—to the point that facilities are being penalized for not having a
certified EHR to document patient information. Schools must also teach using an
EHR in all medical programs so students are better prepared to work and document
within the EHR. However, schools of all medical disciplines must also teach paper

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charting. Because the EHR could go down for maintenance and upgrade, or simply
have a glitch, staff will need to know how to document using both methods for
such instances. Staff and providers must be trained to use healthcare technology
and EHRs so that documentation is complete and thorough, and patient charts
are easily trackable in noting who documented new information and when. Staff
must also maintain such security measures as using only their passwords and not
sharing passwords with anyone.
In addition to extensive training for using technology, providers must also
know which areas of the EHR are mandatory fields to document information
for billing purposes. Compliance departments in hospitals usually assist with
training, alongside a nurse informaticist, to ensure that proper documentation is
covered and staff know which fields of the EHR are used for billing and for quality
management care purposes.
Staff and providers must be trained on viewing only the charts of patients
for which staff and providers are responsible. Now more than ever, many staff
members are fired from their positions and jobs due to curiosity. Years ago, staff
only had access to the paper charts of patients they were taking care of on their floor
or unit. Now, because of technology, staff are able to view any chart of any patient
within the system. Consequently, more compliance audits are being performed
throughout health systems.

Figure 7.5: Healthcare Compliance


Source: 123rf.com
Attribution: User “tumsasedgars”
License: tumsasedgars © 123rf.com. Used with permission.

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Think About This Scenario

A well-known famous person gets admitted to the hospital and comes through
the emergency department for treatment. The patient then is admitted to the
cardiac floor of the hospital. You are working in the hospital on another floor
and hear some nurses talking and looking in the famous person’s chart to see
what happened. What should you do? Should you ignore the situation, report
them, or confront the nurses? These situations occur now because it is so easy
to view charts in the health system on any floor, unit, or department. It is
imperative that staff only view the charts belonging to the patients for whom
they are responsible.
Here is another common scenario: A nurse allows another nurse to use her
password to document in a patient’s chart in the EHR. The nurse who borrowed
the password documents incorrect information, and now the patient has involved
legal teams and support against the hospital. When the chart is audited, they are
involving all parties that logged into the chart to document. The nurse states she
did not document in the chart and she had given her password to another nurse
who documented under her name. Should both nurses be held accountable?
Why or why not?

Technology is vital in healthcare, but compliance must be involved to


ensure that staff members are educated on its use while also protecting patient
information. Privacy in the healthcare system is huge particularly because staff
members have access to some of the most intimate information about a patient’s
health. Cybersecurity is another topic relevant to compliance. When health data
is held or transmitted across networks, it must be secure due to medical records
being targeted by cybercriminals. In these days, many cyber-attacks are happening
in healthcare. In 2015, 113 million health care records were breached (Cashwell,
2018). This rise in cyberattacks and using technology requires healthcare facilities
to focus on cybersecurity compliance, protection, and prevention (Cabrera, 2016).

7.14 DISCUSSION QUESTIONS


1. Why would it be important for users of an electronic medical record to
protect their passwords? Should an employee be held accountable for
situations in which a computer screen is left open for bystanders to view?
Why or why not?
2. Should health care students be given an opportunity to document using
an electronic medical record during their college experience before
getting a job in the workforce? Why or why not?
3. Discuss healthcare exchanges and why they are important moving
forward in healthcare.

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4. List one example by finding an article on a cyber-attack in healthcare.


Discuss the article and what the outcome was.
5. Define meaningful use and why it is used in healthcare.
6. Why is compliance and technology so important in healthcare today?
Discuss education aspects, financial aspects, and quality of care aspects.

7.15 KEY TERM DEFINITIONS


1. HITECH Act- was created to motivate the implementation of electronic
health records and support technology in the U.S.
2. EMR/Meaningful Use Data- the digital equivalent of paper records in
health care.
3. Meaningful Use- using the electronic medical record in a meaningful
way to provide quality of care to the patient.
4. Data Security/Privacy of Information- the process of protecting
data from unauthorized access and without data corruption.
5. Interoperability & Interfaces- the ability of computer systems and
software to exchange and make use of clinical information.
6. Decision Making Support Tools- a wide range of computer-based
tools developed to support decision analysis and processes.
7. Order Entry Systems- replaces more traditional methods of placing
medication orders including written, verbal, and faxed strategies via the
computer versus paper methods.
8. Telehealth—enhancement to healthcare by using a variety of
telecommunication technologies to deliver virtual, medical, health, and
educational services to patients.
9. Clinical Decision Support Systems—health information technology
system designed to provide medical staff and providers with clinical
decision support when making clinical decisions.

7.16 REFERENCES
Agris, J. (2014). Extending the Minimum Necessary Standard to Uses and Disclosures for
Treatment. Journal of Law, Medicine & Ethics, pp. 263-267.
Ahmad, F., Norman, C., O’Campo, P. (2012). What is needed to implement a Computer-
Assisted Health Risk Assessment Tool? An Exploratory Concept Mapping Study.
BMC Med Inform, 12(1), pg. 149.
American Recovery & Reinvestment Act of 2009. Retrieved from: http://www.
govtractus/congress/billepd?bill=h111-1.
American Telemedicine Association (ATA). (2015). Letter to the Telehealth Workgroup.

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Retrieved from: http://www.americantelemed.org/docs/default-source/policy/ata-


comments-on-21st-century-telehealth-package.pdf.
Baker, D., Qaseen, A., Reynolds, P., Garder, L., & Schneider, E. (2013). Design & Use of
Performance Measures to Decrease Low-Value Services & Achieve Cost-Conscious
Care. Annals of Internal Medicine, 158(1), pg. 55-59.
Berner, E. (2009). Clinical Decision Support Systems: State of the Art. Retrieved
from: http://healthit.ahrq.gov/sites/default/files/docs/page/pdf.
Cabrera, E. (2016). Health Care: Cyberattacks and How to Fight Back. Journal of Health
Care Care Compliance. September and October 2016.
Campbell, R. (2013). The Five Rights of Clinical Decision Support: CDS Tools Helpful for
Meeting Meaningful Use. Journal of AHIMA. 84(10), pp. 42-47.
Carney, T., Morgan,G., Jones, J., McDaniel, A., Weaver, B., & Haggstrom, D. (2014).
Using Computational Modeling to Assess the Impact of Clinical Decision Support
within the Community Health Centers. Journal of Biomedical Informatics, 51(1), pg.
200-209.
Cashwell, Glyn (2018). Cyber-Vulnerabilities & Public Health Emergency Response.
Journal of Health Care Law & Policy, 21(29), pp. 29-57.
Centers for Medicaid & Medicare Services. (2018b). Data and program reports.
Retrieved from: https://www.cms.gov/Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html
Center for Information Technology Leadership. (January 2011). The value of healthcare
exchange & interoperability (HIEI). Retrieved from: www.hitdashboard.com/HIEI
Cimino, J., Jing, X., DelFiol, G. (2012). Meeting the electronic health record “Meaningful
Use” criterion for the HL7 info button standard using openinfobutton and the
librarian info button tailoring environment. AMIA Annual Symposium Process, pg.
112-120.
Fleming, N., Culler, S., McCorkle, R., Becker, E., & Ballard, D. (2011). The Financial &
Nonfinancial Costs of Implementing Electronic Health Records. Health Aff, 33 (3).
Gill, J. (2009). EMRs For Improving Quality of Care: Promise & Pitfalls. Fam Med, 41(7),
pp. (513-515).
Greenes, R. (2014). Clinical decision support: The road to broad adoption (2nd ed.).
Philadelphia, PA: Elsevier.
Gold, M. & McLaughlin, C. (2016). Assessing HITECH Implementation and Lessons: 5
Years Later. The Milbank Quarterly, 94(3), pp. 654-687.
HIMSS HIE Toolkit. (2015). Retrieved from: http://www.himss.org/ASP/topics
HIMSS Guide to Participating in a HIE. (2015). Retrieved from: http://www.himss.org/
ASP/topics_FocusDynamic.asp?faid=148.
Jones, S. & Groom, F. (2012). Information and Communciation Technologies in
Healthcare. Boca Raton, FL: CRC Press.

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Kizer, K. (2015). Clinical Integration: A Cornerstone for Population Health Management.


Journal of Healthcare Management, 60(3), pp. 164-168.
Kwon, J. & Johnson, M. (2018). Meaningful Healthcare Security: Dose Meaningful-Use
attestation Improve Information Security Performance?. MIS Quarterly, 42(4), pp.
1043-1067.
McCool, C. (2013). A Current Review of the Benefits, Barriers, and Considerations for
Implementing Decision Support Systems. Online Journal of NSG Informatics, 17(2).
McCarthy, C. & Eastman, D. (2010). Change management strategies for an effective EHR
implementation. Chicago, IL: HIMSS.
McGonigle, D. & Mastrian, K. (2018). Nursing Informatics and the foundation of
knowledge (4thed). Burlington, MA: Jones & Bartlett Learning
Office of the National Coordinator for Health Information Technology (2018)Meaningful
Use. Retrieved from: https://www.healthit.gov/topic/federal-incentive-programs/
meaningful-use
Penafiel, C., Camacho, I., Aiestaran, A., Ronco, M., Echegaray, L. (2014). Disclosure
of Health Information: A challenge of trust between the various sectors involved.
Revista Lativa De Comunicacion Social, 1(69), pp. 35-151.
Pina, I., Cohen, P., Larson, D. Marion, L., Sills, M., Solberg, L., & Zerzan, J. (2015). A
Framework for Describing Healthcare Delivery Organizations & Systems. American
Journal of Public Health, 105(4), pp. 670-679.
Sheroff, J. (2012). Improving outcomes with CDS support: An implementer’s guide (2nd
ed.). Chicago, IL: HIMSS.
Shirley, D. (2011). Project management for healthcare. Boca Raton, FL: CRC Press.
Smith, P. (2003). Implementing an EMR System: One Clinic’s Experience. Fam Prac
Management, 10(5), pp. (37-42).
Souza, N., Sebaldt, R., Mackay, J., Provok, J., et. al. (2011). Computerized Clinical
Decision Support-Systems for Primary Preventative Care: A Decision Maker, 6(87).
Strong, D. (2014). A Theory of Organization-HER Affordance Actualization. Journal of
the Association for Information Systems, 15(2), pp. 53-85.
Totten, A. W. (2019, 10 1). Telehealth: Mapping teh evidence for patient outcomes from
systematic reviews. Technical Brief N. 26. Retrieved from Agency for Healthcare
Research and Quality: http://www.effectivehealthcare.ahrq.gov/reports/final.cfm
Thorpe, J., Gray, E., Cartwright-Smith, L. (2016). Show Us the Data: The Critical
Role Health Information Plays in Health System Transformation. Journal of Law,
Medicine, & Ethics, 44, pp. 592-597.

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8 Special Topics and Emerging

8.1 LEARNING OBJECTIVES


Issues in Healthcare
Management

1. Identify emerging issues in healthcare.


2. Articulate the future of personalized health.
3. Analyze future challenges with health reform.
4. Describe potential future threats and challenges with the healthcare
delivery system.

8.2 INTRODUCTION
The healthcare system is dynamic, constantly changing, and evolving. The
continual emergence of technology has brought the rise of personalized health
care. Changes in health policy and the political landscape continue to bring about
changes in health reform. The ongoing strides toward improving healthcare cost,
quality, and access brings evolution in the healthcare delivery system constantly.
Healthcare providers and organizations should prepare for inevitable changes
by forecasting potential challenges and issues that may arise in the future. This
chapter will discuss special topics and emerging issues in healthcare management
and their relevance to compliance in healthcare organizations.

8.3 KEY TERMS


• Population Health
• Person-centered Care
• Personalized Health care
• Health Reform
• Determinants of Health
• Personalized Medicine

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8.4 EMERGING ISSUES IN HEALTH CARE


8.4.1 Population Health
Historically, healthcare has traditionally focused on treating health from an
individual perspective. In recent years, there has been increasing emphasis on
contributing factors that may impact community health, such as education, income,
genetics, behaviors, and environmental exposures. The population health model
acknowledges these different factors and how their intersection has an impact on
health and focuses on improving health at a group level (Knickman & Elbel, 2019).
The population health model refers to these factors as determinants of health.
Determinants can arise from multiple sources, such as the following: (1) the social
and economic environment, which includes income, education, employment, and
social support; (2) the physical environment, which includes housing, availability
of health foods, and air and water safety; (3) genetics; (4) medical care, which
includes prevention, treatment, and disease management; and (5) health-related
behaviors, which includes smoking, exercise, and diet (Knickman & Ebel, 2019).

Social and
Economic
Environment

Health-
Physical
Related
Environment
Behaviors

Determinants
of Health

Medical
Genetics
Care

Figure 8.1: Determinants of Health


Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

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Strategies for healthcare that strive to improve quality while also reducing the cost
of medical care include appealing to payers, providers, and patients. Population
health management refers to approaches that are developed in order to foster
health and quality of care improvements for a population as a whole while managing
costs (McAlearney, 2012). There are various types of population health strategies.
Lifestyle management strategies aim to improve individual health habits and
reduce health risks by using techniques to promote health behavior change from
a health promotion or prevention standpoint. Demand management strategies
utilize remote patient management tools in order to direct patients toward the
most appropriate medical services. Disease management strategies attempt to
provide medical care management services by focusing on a particular disease and
providing services related to the needs of patients with that condition. Catastrophic
care management strategies focus on providing the services needed by individuals
who suffer from catastrophic illnesses or injuries. Disability management
strategies attempt to bridge the gap between healthcare management and disability
management in order to reduce lost worker productivity due to illness or injury.
Integrated population health management strategies promote comprehensive
health care for each member of a population by coordinating different health and
care management strategies (McAlearney, 2012). Each of these population health
strategies are designed based on specific goals and objectives that would best meet
the needs of patients.

Real-Life Example: Disease Risk Management

Duke University Medical Center developed a telephone-based nurse care


management program that was shown to improve medication adherence
for African American patients with diabetes in rural areas. Nurses called
patients each month for a year to discuss the patients’ cardiovascular disease
risk management. The conversations contained both standard and tailored
components. The nurses’ discussions focused on teaching the dangers of poor
cardiovascular disease control, presenting risk factors clearly and credibly, and
enforcing the saliency of the hazard. At each call, topics for discussion were
chosen based on an assessment of the patient’s knowledge and stage of behavior
change. Nurses then contacted providers at three, six, and nine months to
provide patient updates and to facilitate medication management. All nurses
received training in community health, cultural sensitivity, and motivational
interviewing. The intervention took place in community-based primary care
clinics affiliated with an academic medical center.
The intervention has since been adopted statewide by the North Carolina
Medicaid Agency and expanded to include additional conditions.

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8.5 PERSON-CENTERED CARE


According to the Institute of Medicine (2001), the healthcare delivery system
should revolve around the patient, respect patient preferences, and put the patient
in control of their care (Joshi et. al, 2014). Person-centered care has become a
major focus in healthcare delivery; thus, it is important to think about what types
of services patients would like to see in the future. Table 1 provides results of a
consumer survey conducted in 2018 by the PwC Health Research Institute.

78% of consumers stated that they are interested in having a “menu” of care options
offered by multiple providers, which would allow them to choose care from local
providers or virtual care from specialists across the country.
78% of consumers who had a hospital stay in the last 2 years reported that they believe
at least a few of their recent in-person interactions with providers could have occurred
virtually.
54% of consumers stated that they would choose to receive hospital care at home if it
cost less than the traditional option.
54% of consumers stated that they would be likely to try an FDA-approved app or
online tool for treatment of a medical condition.
47% of consumers would be comfortable receiving health services from a technology
company such as Google or Microsoft.
Table 8.1: Current Consumer Health Care Interests (PwC, 2019)
Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

8.6 FUTURE OF PERSONALIZED HEALTH CARE


Personalized health care is a relatively new approach that is based on the
scientific foundation of systems medicine that recognizes the dynamic relationship
between genetic inheritance, environmental exposures, and systems biology. This
type of health care uses the best predictive tools to identify each individual’s health
risks, the specific mechanism of their disease, and the best therapeutic approaches
directed to their needs through health planning and coordinated care. Personalized
health care can be used to enhance health, prevent disease, track its development,
intervene early, and manage disease most effectively if it occurs (Snyderman, 2011).
Personalized health care and personalized medicine are terms often used
interchangeably, but mean different things. Personalized healthcare is a broad term
that includes any biologic information that helps predict risk for disease or how a
patient will respond to treatments, while personalized medicine refers specifically
to the use of genetics and genomics. An example of personalized healthcare is
including specific biomarkers like lipoprotein that can help to better predict
risk for heart disease or stroke in some individuals. An example of personalized
medicine includes using specific tumor markers to guide therapy for breast cancer
(Cleveland Clinic, 2012).

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There are many benefits to using personalized health care. For one, personalized
health care can improve the quality of care and decrease cost at the same time
by helping us predict the right therapy with the fewest side effects for individual
patients. Personalized health care can also help to engage patients in their care
(Cleveland Clinic, 2012).

Real-Life Example: Personalized Health Care

Orlando Health uses large amounts of patient data to provide personalized communication
to new mothers. Moms can choose a track to focus on—such as caring for a new baby
or caring for family—and receive regular, personalized emails to address questions they
may have. Instead of aimlessly searching the internet for help, new moms can get their
individual questions answered right in their inbox.

8.7 CHALLENGES WITH HEALTH REFORM


Health reform is not a new concept; however, it will continue to take center
stage for the coming years. Efforts towards creation of universal health coverage in
the U.S. began in the early 1900s. Most of the other industrialized countries in the
world have successful universal health care programs. Universal health coverage
refers to a system in which health care is provided to all residents of that country
or region. This is typically referred to as national health insurance (NHI), which
is a health care financing system run by the government (Goldsteen & Goldsteen,
2013). The first NHI program appeared in the world in the 1880s, and most of
the european industrialized countries had some kind of NHI system by the 1920s.
The first campaign for a NHI program in the U.S. began in the early 1900s and
was pushed by the American Association for Labor Legislation (AALL). President
Teddy Roosevelt also proposed social insurance as part of his platform in 1912
(Goldsteen & Goldsteen, 2013). Over the years, many attempts at health reform
were unsuccessful (table 2). Arguably, the most successful attempt at health reform
in the U.S. was the Patient Protection and Affordable Care Act (PPACA) of 2010.
However, as discussed in chapter 6, there have already been changes to the PPACA
under the Trump administration, and we will likely continue to see changes. Health
reform will continue to be a heavily debated topic in the coming years.

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Year Attempt at Health Reform


1912 Teddy Roosevelt and the progressive party endorsed social insurance as
part of their platform, which included health insurance.
1915 The American Association for Labor Legislation (AALL) published a
draft bill for compulsory health, which was initially supported by the
American Medical Association (AMA), but the AMA reversed their
position by 1920.
1930 – 1934 President Franklin D. Roosevelt appointed a committee to work on social
policies to secure employment, retirement, and medical care but did not
risk the passage of the Social Security Act to advance national health
reform.
1935 – 1939 President Franklin D. Roosevelt pushed for national health insurance
after the Social Security Act passed, but Congress did not support
government expansions.
1944 President Franklin D. Roosevelt outlined the economic bill of rights in
his State of the Union address, which included the right to adequate
medical care and the opportunity to achieve and enjoy good health.
1945 – 1949 President Truman continued to pursue a national health program after
the end of World War II, but the fear of socialism and power of southern
democrats blocked all proposals.
1954 President Eisenhower proposed a federal reinsurance fund to enable
private insurers to broaden the groups of people they cover.
1965 Medicare and Medicaid programs were signed into law.
1977 President Carter proposed Medicaid expansion for poor children under
age 6, but the proposal failed to come to a vote in Congress.
1993 President Clinton’s proposal, the Health Security Act, was introduced in
both houses of Congress but gained little support.
1993 Other national health reform proposals were introduced in Congress
but failed to receive sufficient support for passage. These proposals were
the McDermott/Wellstone Single Payer Health Insurance Proposal and
Cooper’s Proposal for Managed Competition Without a Guarantee of
Universal Coverage.
2006 Massachusetts passed and implemented legislation to provide health
care coverage for nearly all state residents.
2006 Vermont passed comprehensive health care reform aiming for near-
universal coverage.
2007 California failed in its attempt to pass a health reform plan with an
individual mandate and shared responsibility for financing the costs.
2010 The Patient Protection and Affordable Care Act was passed.
Table 2: History of Health Reform in the U.S. (Kaiser, 2011)
Source: Original Work
Attribution: Lesley Clack
License: CC BY-SA 4.0

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8.8 WORKFORCE ISSUES


Currently, the U.S. is facing shortages in healthcare workers across the care
delivery spectrum. According to the Association of American Medical Colleges
(2019), the U.S. is facing a shortage of between 46,900 and 121,900 physicians by
2032. The American Hospital Association (2019) has reported that they support
the Resident Physician Shortage Reduction Act, which is legislation that would
add 15,000 residency positions funded by Medicare over five years in order to
alleviate physician shortages that threaten patient access to care. Shortages are
also prevalent in other healthcare occupations. An expected shortage of Registered
Nurses (RNs) is expected to grow due to the increased aging of the population. The
Bureau of Labor Statistics’ (BLS) employment projections for 2016 – 2026 stated
that the RN workforce is expected to grow from 2.9 million in 2016 to 3.4 million
in 2026. The BLS report also projected that there would be an additional 203,700
new RNs needed each year through 2026. The American Association of Colleges of
Nursing (AACN) is working with schools, policy makers, and nursing organizations
in order to bring attention to this issue and is leveraging its resources to shape
legislation, identify strategies, and form collaborations to address the shortage.
Another potential strategy for solving the physician workforce shortage is the
use of mid-level practitioners, such as Nurse Practitioners (NPs) and Physician
Assistants (PAs). An increased share of healthcare services are now provided by
NPs and PAs. According to a New England Journal of Medicine study, the number
of NPs and PAs nearly doubled between 2001 and 2016, and those trends are
projected to continue through 2030 (Auerbach, Staiger, & Buerhaus, 2018).

Real-Life Example: State Approaches to Workforce Shortages

Iowa enacted a law in May 2019 that will provide opportunities for residency
students to participate in rural rotations for exposure to such areas of the state.
The University of Iowa will also conduct a physician workforce study on the
state’s workforce challenges related to recruitment and retention of primary care
and specialty physicians. The study will examine current physician workforce
data, identification of projected physician workforce shortages by region of the
state, and analysis of the availability of residency positions, with an emphasis on
the need for recruitment and retention of physicians in rural Iowa.

8.9 IMPLICATIONS FOR COMPLIANCE


Staying on top of emerging issues and trends is especially important in
healthcare compliance. Practicing population health and person-centered care
are both important to accreditation requirements. The ever-changing landscape
of health reform brings about the need to comply with new laws and regulations.
For example, personalized health care brings about an entirely different area
of compliance, such as regulations on the use of genetic information. There are

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also future directions and trends in compliance. Organizations will integrate


compliance programs from across the organization in order to increase efficiency.
And compliance functions will use technology and data analytics more effectively
for monitoring compliance issues (Deloitte, 2016).

8.10 SUMMARY
Many emerging trends and challenges in healthcare will potentially change the
landscape of healthcare delivery in the future. Emerging issues such as population
health and person-centered care change the ways in which providers interact with
patients. New innovations such as personalized care have the potential to change
the ways in which patients approach care. The ongoing debate over health reform
in the U.S. brings with it a unique set of challenges, such as potential new laws
and regulations that change how organizations deliver care. The challenges with
adequate healthcare workforce impact all of these factors as well. These emerging
trends and issues are all important to compliance; thus, healthcare providers and
organizations should forecast for upcoming trends and changes.

8.11 DISCUSSION QUESTIONS


1. Discuss the difference between a population health approach to care
delivery and a medical or individual approach to care delivery.
2. Your health insurance company informs you that they are now providing
you with access to personalized live video doctor visits to assess
symptoms, diagnose conditions, and write prescriptions. You will be
able to get personalized care that addresses your unique medical history
while still having the convenience of staying at home. Would you use this
service instead of your regular physician? Why or why not?
3. There have been many attempts at universal health coverage in this
country, and all have been unsuccessful. Do you feel that universal health
coverage is possible in the U.S.? What would have to happen in order to
be able to implement universal health coverage in the U.S.?

8.12 KEY TERM DEFINITIONS


1. Population Health- approaches that are developed in order to foster
health and quality of care improvements for a population as a whole.
2. Person-centered care- care that revolves around the patient, respects
patient preferences, and puts the patient in control of their care.
3. Personalized Health Care- use of any biological information to identify
each individual’s health risks, the specific mechanism of their disease,
and the best therapeutic approaches directed to their needs through

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health planning and coordinated care.


4. Health Reform- governmental policy that affects health care delivery.
5. Determinants of Health- contributing factors that may have an
impact on health, such as education, income, genetics, behaviors, and
environmental exposures.
6. Personalized Medicine- the use of genetics and genomics to predict risk
for disease or how a patient will respond to treatments.

8.13 REFERENCES
American Hospital Association (AHA). AAMC Updates Physician Shortage Projections.
Retrieved from https://www.aha.org/news/headline/2019-04-25-aamc-updates-
physician-shortage-projections
American Association of Colleges of Nursing (AACN). (2016). Nursing Shortage.
Retrieved from https://www.aacnnursing.org/News-Information/Fact-Sheets/
Nursing-Shortage
Association of American Medical Colleges (AAMC). (2019). 2019 State Physician
Workforce Data Report. Retrieved from https://store.aamc.org/downloadable/
download/sample/sample_id/305/
Auerbach, D.I., Staiger, D.O., & Buerhaus, P.I. (2018). Growing Rates of Advanced
Practice Clinicians- Implications for the Physician Workforce. NEJM Catalyst.
Retrieved from https://catalyst.nejm.org/advanced-practice-clinicians-nps-and-pas/
Bureau of Labor Statistics. (2016). Employment Projections for 2016 – 2026. Retrieved
from https://www.bls.gov/ooh/healthcare/registered-nurses.htm
Cleveland Clinic. (2012). What is Personalized Healthcare? Retrieved from https://
health.clevelandclinic.org/what-is-personalized-healthcare/
Deloitte. (2016). New Horizons: Compliance 2020 and Beyond. Retrieved from https://
www2.deloitte.com/content/dam/Deloitte/uk/Documents/risk/deloitte-uk-
compliance-thought-leadership-16.pdf
Goldsteen, R.L. & Goldsteen, K. (2013). Jonas’ Introduction to the U.S. Health Care
System, 7th edition. New York, NY: Springer Publishing.
Joshi, M.S., Ransom, E.R., Nash, D.B., & Ransom, S.B. (Eds.) (2014). The Healthcare
Quality Book: Vision, Strategy, and Tools, 3rd edition. Chicago, IL: Health
Administration Press.
Kaiser Family Foundation (KFF). (2011). History of Health Reform in the U.S. Retrieved
from https://www.kff.org/wp-content/uploads/2011/03/5-02-13-history-of-health-
reform.pdf
Knickman, J.R. & Elbel, B. (2019). Jonas & Kovner’s Health Care Delivery in the United
States, 12th edition. New York, NY: Springer Publishing.

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McAlearney, A.S. (2012). Population Health Management: Strategies to Improve


Outcomes. Chicago, IL: Health Administration Press.
PwC. (2019). Top Health Industry Issues of 2019: The New Health Economy Comes of
Age. Retrieved from https://www.pwc.com/us/en/industries/health-services/pdf/
pwc-us-healthcare-top-health-industry-issues-2019.pdf
Snyderman, R. (2011). Personalized healthcare: From theory to practice. Biotechnology
Journal, 7, 973-979.

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